Class II
Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
Mangalm LLCfood
FDA Recalls in Washington
2001 recalls distributed in Washington
Class II
Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct. Retail bag UPC: None. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/12ct. bags per case. Case UPC 10071757080246. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted Corn & Red Bell Peppers Prepared with Sweet Soy Sauce Infused Rice. Net wt. 17oz. Retail box UPC 010878810915. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/17oz. boxes per case. Case UPC 10010878810912. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
Mangalm LLCfood
Class II
Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Item 5650233 Trader Joe's Vegetable Fried Rice, net wt. 1lb per bag. Retail bag UPC 00521482. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10052148200001. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Tops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:***Mustard Oil*** Tops GOLD Mixed Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288612950 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
Mangalm LLCfood
Class II
Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. Consumer package is a plastic cup with foil lid and clear plastic lid. UPC 0 21130 07662 8. Distributed by Lucerne Foods, Inc PO Box 99, Pleasanton, CA. Product is distributed in a 6-pack case that consists of a flat cardboard tray and clear plastic film. There are no graphics on the distribution unit. The cases are broken down and product is merchandised as a single 24 oz.
Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.
Class II
Chilli Spanish Peanuts, Treasured Harvest brand, 25lb clear plastic bag container. UPC:none Item code: 2608-25
Foreign object (glass) found inside sealed container of finished product.
Class II
King Harvest brand Roasted Red Pepper Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Roasted Red Pepper Hummus 10 oz. UPC 025726 311278 Roasted Red Pepper Hummus 17 oz. UPC 025726 311261
Foreign material (aluminum pieces).
Class II
SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, SPICES (INCLUDING PAPRIKA AND TUMERIC), NATURAL FLAVOR, GARLIC), HONEY, WATER, DISTILLED VINEGAR, SUGAR, TOMATO CONCENTRATE, HABANERO PEPPERS, GARLIC, SPICES, SALT, ONION, POTASSIUM SORBATE, SODIUM BENZOATE, NATURAL FLAVOR UPC 8 50033 93758 9 BOTTLED BY: BOBBEES FOR SAVANNAH BEE COMPANY 211 JONNY MERCER BLVD, SAVANNAH, GA 31410
Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard", but the product inside the bottle is a different flavor of BBQ sauce. After investigation, the firm determined that the product in the bottle is their Honey BBQ Sauce "Sweet". The BBQ sauce "Sweet" contains wheat and soy which is not listed on the BBQ Sauce "Mustard" label.
Class II
Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UPC 011110041623. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/22oz. boxes or 8.25 lbs. per case. Case UPC 10011110041620. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10097908500001. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
King Harvest brand Black Olive Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Black Olive Hummus 10 oz. UPC 025726 311216
Foreign material (aluminum pieces).
Class II
Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Tops GOLD Lime Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611397 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
Mangalm LLCfood
Class II
King Harvest brand Jalapeno Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Jalapeno Hummus 10 oz. UPC 025726 310042 Jalapeno Hummus 17 oz. UPC 025726 310059
Foreign material (aluminum pieces).
Class II
Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Tops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:***Mustard Oil*** Tops GOLD Mango Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288611915; 8904288613025 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
Mangalm LLCfood
Class II
Chilli Spanish Peanuts, First Street brand, 11oz clear plastic container. UPC: None Item Code: 2608-T20
Foreign object (glass) found inside sealed container of finished product.
Class II
Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, edamame, and other colorful vegetables in an umami dashi sauce Net wt. 17oz. Retail box UPC 071757508934. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/17oz. boxes or 8.5 lbs. per case. Case UPC 10071757508931. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
King Harvest brand Balsamic Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Balsamic Hummus 10 oz. UPC 025726 310097
Foreign material (aluminum pieces).
Class II
Item 6430153 Ajinomoto Vegetable Gyoza Dumplings. Net wt. 24.7oz. per bag. Retail box UPC: 071757010109. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/24.7oz bags or 12.34lb. per case. Case UPC 10071757010106. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Class II
Tops GOLD Khatta Meetha Pickle NET QTY.: 33.51oz PRODUCT OF INDIA UPC: 8904288611427 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
Mangalm LLCfood
Class II
King Harvest brand Spinach Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Spinach Hummus 10 oz. UPC 025726 311087
Foreign material (aluminum pieces).
Class II
King Harvest brand Sundried Tomato Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Sundried Tomato Hummus 10 oz. UPC 025726 311186.
Foreign material (aluminum pieces).
Class II
Great Value Fat Free Cottage Cheese Small Curd 0% Milkfat NET WT 24OZ UPC 0 78742 37339 3 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
Class II
Great Value Lowfat Cottage Cheese Small Curd 2% Milkfat NET WT 24OZ UPC 0 78742 11673 0 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
Class II
Great Value Cottage Cheese Small Curd 4% Milkfat NET WT 16oZ UPC 0 78742 37235 8; 24oz UPC 0 78742 37236 5 & 3lb UPC 0 78742 14797 0 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
Class III
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Class I — Urgent
Dreamland's Zaatar Chickpea Salad is packaged in poly bags with a generic label which declares "chickpeas, cumin, zataar, turmeric, dill, onion, garlic, parsley". Dreamland distributed bulk cases (2/5lbs. bags per case) to Haggen store. Bulk 5lbs. bags were not sold directly to consumers. Haggen stores unpacked 5lb. bags of chickpea salad into cold food pan at salad bar (without mixing with other ingredients), consumers packed product in grab & go containers, and Haggen applied scale label when members paid at the register.
Undeclared Sesame, Soy, Wheat
Dreamland Incfood
Class II
CLOVER SONOMA COTTAGE CHEESE LOW FAT 2% MILKFAT NET WT 16OZ UPC 0 70852 54400 7 & 32OZ UPC 0 70852 54200 3 DISTRIBUTED BY: CLOVER-STORNETTA FARMS LLC PETALUMA, CA 94952
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
Class II
CLOVER SONOMA SOUR CREAM NET WT 8OZ UPC 0 70852 61800 5 & 16OZ UPC 0 70852 61500 4 DISTRIBUTED BY: CLOVER-STORNETTA FARMS LLC PETALUMA, CA 94952
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
Class III
C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.
Class I — Urgent
Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 capsules per bottle; Distributed by: Ambrosia Brands, LLC, 625 Randall Ave, St. 100, Cheyenne, WY 82001; SUGGESTED USE: As a dietary supplement, take two (2) veggie capsules once a day. For best results, take 20-30 min before a meal with an 8oz. glass of water or as directed by your health professional; UPC: 8 60012 16172 0
Product may be contaminated with Salmonella
Class I — Urgent
Fish Ball, Frozen, 40 pieces per pack, 200g Wt. UPC# 810093891338
Undeclared allergen ingredient (Wheat and Sesame)
Class I — Urgent
Fish Ball, Frozen, 4 pieces per pack, 5lbs Wt. UPC# 810093891320
Undeclared allergen ingredient (Wheat and Sesame)
Class I — Urgent
NAVITAS ORGANICS ORGANIC CHIA SEEDS NET WT 8 OZ (227g) INGREDIENTS: CERTIFIED ORGANIC CHIA SEED (SALVIA HISPANICA). Product of Mexico/Argentina/Paraguay. Distributed by Navitas Organics Novato, CA USA 94949 UPC: 858847000284
Potential contamination with Salmonella.
Navitas, LLC.food
Class I — Urgent
Fish Ball, Frozen, 20 pieces per pack, 400g Wt. UPC# 810093891325
Undeclared allergen ingredient (Wheat and Sesame)
Class II
Yoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
SB FOOD LLCfood
Class II
Yoyo Gummy Tropical Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
SB FOOD LLCfood
Class II
Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.
Class II
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
SB FOOD LLCfood
Class I — Urgent
IQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305
Listeria monocytogenes
Class I — Urgent
Prime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211, USA; Product must be thoroughly cleaned and cooked before consumption.; PRODUCT OF VIETNAM; UPC: 6 946976 818000
Uneviscerated Fish
Class I — Urgent
Why Not Natural Moringa Capsules 120 capsule bottle marked with lot # A25G051 on the bottom and with an expiration date of 07/2028 stamped on the bottom.
Potential to be contaminated with Salmonella
Class II
Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sold in case lots)
Label declares bovine colostrum but does not declare milk allergen.
Class I — Urgent
The Tuna Salad product container is mislabeled with a Chicken Salad lid, which states: Molly Kitchen's Chicken Salad, (item#) 789953, NET WT. 5 LB (2.26 kg) per plastic tub. UPC 7 5810830149 8. Distributed by US Foods, Inc. Rosemont, IL 60018 Contains: Eggs, Milk, Wheat. The immediate 5-lb tub has no side labeling (besides the lid). The master cardboard case label is correct and states: Molly Kitchen's Tuna Salad, (item #) 794599, 2/5 LB tubs per case, Net Wt. 10 LB (4.53 kg). UPC 075810876447. Distributed by US Foods, Inc. Rosemont, IL 60018. Contains: Egg, Wheat, Fish (Tuna).
Undeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.
Class II
CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/STRAWBERRY JAM NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328 CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/STRAWBERRY JAM NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
Foreign material. During production, the firm found pieces of blue plastic in a filter.
Class II
CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328 CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
Foreign material. During production, the firm found pieces of blue plastic in a filter.
Class II
Sonic Tots, item number SON00543. Frozen potato product is packaged in clear unlabeled poly bags (6/5 lb), Net Wt 30 lbs (13.61 kg)/ case. UPC 0 00 72714 00543 5. Manufactured By: McCain Foods USA Inc. Oakbrook Terrace, IL.
Foreign material (small hard plastic fragments).
Class II
Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag (6/5 lb bags), Net Wt. 30 lbs (13.6 kg)/ case. UPC on 30 lbs case label: 1 00 72714 00215 8. Manufactured by McCain Foods USA Inc. McCain distributed this product to foodservice accounts and product was not sold at retail stores.
Foreign material (small hard plastic fragments).
Class I — Urgent
Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.
Undeclared hazelnut.
Class II
CREAMY PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY US FOODS, ROSEMONT, IL 60018; PEANUT BUTTER NET WT. 0.5OZ & NET WT 0.75OZ DIST BY: DYMA BRANDS, INC. ATLANTA, GA 30328; Product also sold under the following brand names: FLAVOR Fresh PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY: DYMA BRANDS, INC. ATLANTA, GA 30328; HOUSE RECIPE CREAMY PEANUT BUTTER NET WT 0.75 OZ (21.2g) DISTRIBUTED BY SYSCO COROPRATION, HOUSTON, TEXAS 77077; Katy's Kitchen SMOOTH PEANUT BUTTER NET WT 0.75 OZ (21g) MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTIN, TX 77043 PEANUT BUTTER creamy NET WT 0.75 OZ (21g) FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE WYOMING, MI 49509; CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
Foreign material. During production, the firm found pieces of blue plastic in a filter.
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Authority, 4. Climax Molybdenum, A Freeport-McMoRan Company, 5. University of Maryland, School of Public Policy, 6. Liberty University Environmental Health & Safety, 7. Subaru, 8. Trinity Cyb3r, 9. Candy Treats, 10. JSE, Jordan & Skala Engineers, 11. Dropbox DocSend, 12. PP, Prosperity Promotions, 13. Northwest Indian College Foundation, 14. FES Branding Solutions, 15. Berkshire Hathaway Guard Insurance Companies, 16. merry maids Annual 26 Conference, 17. BW, Best Western, 18. Morgan Stanley, 19. tufin, 20. Compliments of Pioneer, 21. A.D. Morgan, Construction Manager, Design Builder, General Contractor, 22. Adobe, 23. xfinity, 24. Fundermax Interiors, 25. White Cup, 26. Acadia Commercial, 27. Aviagen, 28. ORG Expo, 29. Make Your Mark For nutrition facts, information, and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Undeclared allergens (milk, soy, and peanut)
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
potential Clostridium botulinum contamination
Diva Fam Incfood
Class I — Urgent
JUICE from the Raw, cashew milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Pineapple- UPC# 5065006235288
potential Clostridium botulinum contamination
Diva Fam Incfood
Class I — Urgent
JUICE from the Raw, cashew coffee milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class I — Urgent
Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
Class I — Urgent
JUICE from the Raw, pineapple mint
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Cherry- UPC# 5061033691264
potential Clostridium botulinum contamination
Diva Fam Incfood
Class I — Urgent
JUICE from the Raw, spicy lemonade
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Elderberry- UPC# 5065006235189
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
potential Clostridium botulinum contamination
Diva Fam Incfood
Class I — Urgent
Spice Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
Class I — Urgent
Bread and Roll Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
Class II
Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Undeclared allergens (milk, soy, and peanut)
Class III
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.
Optiwize Inc.food
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
Product contains salt and is mislabeled
Class III
Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.
Fazt & Loud LLCfood
Class II
spicely ORGANIC sumac NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2oz (56g) Ingredients: Organic Sumac, Salt www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007339
Product contains salt and is mislabeled
Class I — Urgent
JUICE from the Raw, upbeat
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
CINNAMON POWDER NET WT : 3.5 oz (100g) PRODUCT OF INDIA UPC 7 46241 29537 8 Distributed by: Venzu Traders LLC venzutraders@outlook.com
Potential contamination with heavy metal (lead).
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango and Pineapple- UPC# 5065006235301
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Blue Spirulina and Raspberry- UPC# 5065006235813
potential Clostridium botulinum contamination
Diva Fam Incfood
Class II
spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2.4oz (68g) Ingredients: Salt, *Celery Seeds *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007605
Product contains salt and is mislabeled
Class II
WinCo Foods Deli Margherita Pizza Thin Crust, Item #67279. Net wt. 17oz. UPC 0267279 807987. Product is Take & Bake and sold refrigerated in a plastic flexible film as a single retail unit with a 5 day Sell-By date. Distributed by WinCo Foods 650 N. Armstrong Pl. Boise, ID.
Product may contain foreign material (metal fragments).
WinCo Foods LLCfood
Class I — Urgent
JUICE from the Raw, sweet greens
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class I — Urgent
JUICE from the Raw, DETOX GREENS
Under-processed product may contain pathogenic bacteria that could harm to humans.
Everpress Juicefood
Class I — Urgent
Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day supply; NET WT. 8.5OZ (240G); Manufactured for Superfoods, Inc.; UPC: 860013190804 b.) Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30-0.28oz (8g) STICKS - NET WT. 8.47oz (240g); Manufactured for Superfoods, Inc.; UPC: 850077468063
Products may be contaminated with Salmonella Typhimurium
SUPERFOODS, INC.food
Class I — Urgent
a.) Live it Up brand Super Greens; Natural Wild Berry Flavor; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day supply; NET WT. 9.49oz (269.16g); Manufactured for Superfoods, Inc.; UPC: 860013190811 b.) Live it Up brand Super Greens; Natural Wild Berry Flavor; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30-0.32oz (9g) STICKS - NET WT. 9.52oz (270g); Manufactured for Superfoods, Inc.; UPC: 850077468070
Products may be contaminated with Salmonella Typhimurium
SUPERFOODS, INC.food
Class I — Urgent
Healthy Truth brand Moringa Powder; 5lb and 20lb
Products may be contaminated with Salmonella Richmond.
Class I — Urgent
Fran s PureBar Almondmilk Chocolate 46% Madagascar Plant-Based, net wt. 1.1oz, UPC 7 49668 24280 2. Ingredients: Sugar, cocoa butter, cocoa beans, almonds, sunflower lecithin, vanilla extract. May contain traces of milk, peanuts and sesame. Fran's Chocolates, Ltd. Seattle, WA 98108.
undeclared hazelnut.
Class I — Urgent
HerbsForever- Gastro Care; Ayruvedic Herbal Supplement; 90 VEGE Capsules; Extract 800 MG each capsule. UPC: 8 07814 00124 3
Potential undeclared allergen ingredient (Wheat)
Herbs Foreverfood
Class II
Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6
elevated levels of chloramphenicol in frozen shrimp
AZ Gems, Inc.food
Class II
So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL). UPC 744473 476138. Manufactured By/For So Delicious Dairy Free Eugene, OR 97402 So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. Net wt. 500mL. UPC 744473 276134. Product of the U.S.A. Distributed by Danone Inc., Boucherville, Quebec J4B 1E6
Foreign material
Class I — Urgent
HerbsForever- Hingwastika Churna ; Ayruvedic Herbal Supplement; 90 VEGE Capsules; 100 GMS UPC: 8 07814 00622 4
Potential undeclared allergen ingredient (Wheat)
Herbs Foreverfood
Class II
Sysco Imperial Potato Tater Barrel, item number 1000006067. Frozen potato product is packaged in 6/5 lb. clear unlabeled poly bags per case. UPC 1 07 34730 62740 0. Distributed by Sysco Corporation, Houston, TX. Product of U.S.A.
Clear hard plastic fragments.
Class II
Spicy Breakfast Burrito, Sprig & Sprout brand, Ready to Eat. Refrigerated. Net wt. 9.1oz. UPC 100001000297, SS00297v02. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
Class II
Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 843784003573, 843784003580
Product found to contain leachable lead levels.
Class I — Urgent
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Product tested positive for Listeria Monocytogenes.
Class II
Baraka French Style Puff Pastry 1lb and 1.5lbs sizes, UPCs 8 22514 28540 3 and 8 22514 28550 2, both sizes 12 retail units per wholesale case
May contain partially hydrogenated oils
Class II
Spicy Veggie Breakfast Burrito, Fresh to You, Ready to Eat, Refrigerated. Net wt. 9.1oz. UPC 100000010310, LPK110310V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057
Foreign material.
Class II
Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.
Clear hard plastic fragments.
Class II
Italian Parsley packaged in 24lb boxes, 40 bunches per box in plastic.
pathogen Cyclospora cayetanensis
Class I — Urgent
Boar's Head Pecorino Romano Grated, 5-pound plastic bag (unit)
Product tested positive for Listeria Monocytogenes.
Class II
Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
May contain partially hydrogenated oils
Class I — Urgent
Pinna Grated Pecorino Romano 2/10, 10-pound plastic bags (units)
Product tested positive for Listeria Monocytogenes.
Class II
Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
Class I — Urgent
Ambriola Piccante grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Product tested positive for Listeria Monocytogenes.
Class II
Eggs Potatoes Cheese Tacos, Evergreen Refreshments brand, Ready to Eat, Refrigerated. Net wt. 6.3 oz. UPC 100040103898, EG03698v01. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
Class I — Urgent
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
Product tested positive for Listeria Monocytogenes.
Class I — Urgent
Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
Product tested positive for Listeria Monocytogenes.
Class I — Urgent
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Product tested positive for Listeria Monocytogenes.
Class I — Urgent
Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case
Product tested positive for Listeria Monocytogenes.
Class II
Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate GF V. Product is shelf stable, gold foil wrapping with paper label and cardboard outer box in some cases. Oregon Bark 2630 NE Sandy Blvd. Portland, Oregon 97232 2 Bars Boxes marked 50/50 or Nutty 4 Bars Boxes marked 50/50 or NUTTY 24 count boxes labeled Nutty UPC 852905007024 (1.2oz) UPC 852905007055 (2.2oz) UPC 852905007031 (4.5oz)
Foreign material.
Tom Bumble LLCfood
Class III
1) Paw Patrol Heart-Shaped Gummy Candies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643846, Distributed by Bendon, Inc. 2) Mickey Mouse Heart-Shaped Gummies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643853, Distributed by Bendon, Inc. 3) Stitch Heart-Shaped Gummies, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643860, Distributed by Bendon, Inc. 4) SpongeBob Squarepants Heart-Shaped Gummy Candy, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219644225, Distributed by Bendon, Inc. 5) Toy Story Multipack Size Gummies, Mixed Fruit, Net Wt. 6.35 oz (180g), packaged in a plastic bag containing 20 mini size packs (0.4 oz each), UPC 805219643914, Distributed by Bendon, Inc.
Unapproved color additive - chlorophyllin copper complex
Class II
Product: Zimi Kunefe Ready to eat (Frozen) Package Size and quantity per case: 380 g paper carton/tray - 9/case UPC: 5201592015822
partially hydrogenated oils (PHOs) in foods exported to the US
Class II
Product: Zimi Puff Pastry French Style (frozen) Package Size and quantity per case: 700 g paper carton - 12/case UPC: 5201592020017. Frozen.
partially hydrogenated oils (PHOs) in foods exported to the US
Class I — Urgent
Choceur Pecan Cranberry & Cinnamon Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095829. Wholesale unit is split case, with 9 of each item per case.
Undeclared wheat
Class I — Urgent
Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale unit is split case, with 9 of each item per case.
Undeclared pecan
Class I — Urgent
Food to Live brand ORGANIC MORINGA LEAF POWDER, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 2 lb., 4 lb., 8 lb., 16 lb., and 44 lb. bags; Ingredients: ORGANIC MORINGA LEAF POWDER; UPC: 8 oz - 840374833268 1 lb. - 840374812881 2 lb. - 840374813109 4 lb. - 840374810283 8 lb. - 840374833275 12 lb. - 840374812898 16 lb. - 840374812904 44 lb. - 840374833282
Contaminated with Salmonella
Lexunder Incfood
Class I — Urgent
Food to Live brand ORGANIC SUPERGREENS POWDER MIX, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 1.5 lb., 3 lb., 6 lb., 12 lb.; Ingredients: ORGANIC KALE; ORGANIC MORINGA LEAF; ORGANIC WHEAT GRASS; ORGANIC SPIRULINA UPC: 8 oz. - 810097461475 1 lb. - 810097461482 1.5 lb. - 810097461499 3 lb. - 810097461505 6 lb. - 810097461512 12 lb. - 810097461529
Contaminated with Salmonella
Lexunder Incfood
Class I — Urgent
Sticker label (for Loose Bulk - peppermint peaches): 4401
Potential contamination with Listeria monocytogenes.
Class I — Urgent
UPC 8 98429 00266 4 Peppermint Peach PROUCE OF U.S.A. 4 COUNT MIN. WT. 2.25 LBS MOONLIGHT PACKING CORPORATION REEDLEY, CA 93654
Potential contamination with Listeria monocytogenes.
Class I — Urgent
UPC 8 10248 03087 1 Peppermint Peach WHITE PEACHES READY TO EAT FROM CALIFORNIA PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654 UPC 8 10248 03163 2 Peppermint Peaches WHITE PEACHES READY TO EAT FROM CALIFORNIA PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654
Potential contamination with Listeria monocytogenes.
Class I — Urgent
UPC 8 98429 00209 1 PEACHES PRODUCE OF U.S.A. NET WT 2 LB (32 OZ) 907 g DISTRIBUTED BY MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654 UPC 0 11110 18174 9 PEACHES PRODUCE OF USA NET WT 32 OZ (2 LB) 907g DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
Potential contamination with Listeria monocytogenes.
Class II
3 B Cookware 6
Potential contamination due to leachable lead.
Class I — Urgent
UPC 8 10248 03186 1 WHITE PEACHES CALIFORNIA FRUIT PRODUCE OF U.S.A. NET WT. 2 LBS. (907G) MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654
Potential contamination with Listeria monocytogenes.
Class I — Urgent
Sticker label (for Loose Bulk - white peaches): 4401
Potential contamination with Listeria monocytogenes.
Class II
3 B Cookware 5
Potential contamination due to leachable lead.
Class I — Urgent
UPC 8 10248 03165 6 YELLOW Peaches PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654 UPC 8 98429 00220 6 YELLOW Peaches from California PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654
Potential contamination with Listeria monocytogenes.
Class I — Urgent
Sticker label (for Loose Bulk - yellow peaches): 4044
Potential contamination with Listeria monocytogenes.
Class II
3 B Cookware 4
Potential contamination due to leachable lead.
Class I — Urgent
Sticker label (for Loose Bulk - peppermint peaches): 4401
Potential contamination with Listeria monocytogenes.
Class I — Urgent
1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve Packets
Contaminated with Clostridium botulinum
ByHeart, INC.food
Class I — Urgent
UPC 8 10248 03186 1 Peppermint Peach PRODUCE OF U.S.A. NET WT. 2 LBS. (907G) MOONLIGHT PACKING CORPORATION REEDLEY, CA 93654
Potential contamination with Listeria monocytogenes.
Class I — Urgent
Sticker label (for Loose Bulk - yellow peaches): 4044
Potential contamination with Listeria monocytogenes.
Class II
Happy Farms by Aldi Italian Style shredded cheese blend (containing low-moisture part-skim mozzarella, not-smoked provolone, romano, asiago & parmesan finely shredded cheeses), 12 oz., individually packaged in a plastic bag, UPC 4061463330949, 6/combo case also containing 6 bags of Taco Style product
Potential metal fragments from supplier raw material (downstream recall)
Class II
Low-moisture part-skim mozzarella shredded cheese, individually packaged in a plastic bag, as: 1) Always Save - Shredded, 5 lb., UPC 7003865782, 4/case 2) Borden - Shredded, 8 oz., UPC 5300007162, 6 or 12/case - Thick Cut, 8 oz., UPC 5300007170, 6/case 3) Brookshire's - Finely Shredded, 8 oz., UPC 9282510119, 12/case - Shredded, 8 oz., UPC 9282510120, 12/case - Shredded, 32 oz., UPC 9282510130, 6/case - Thick Cut, 8 oz., UPC 9282592197, 12/case 4) Cache Valley Creamery - Shredded, 8 oz., UPC 7495802553, 6 or 12/case 5) Chestnut Hill - Fancy Shredded, 8 oz., UPC 3225116742, 6/case 6) Coburn Farms - Shredded, 8 oz., UPC 5193331657, 12/case - Shredded, 12 oz., UPC 5193321820, 18/case - Shredded, 32 oz., UPC 5193334257, 6/case 7) Econo - Shredded, 8 oz., UPC 893800294, 12/case 8) Food Club - Finely Shredded, 8 oz., UPC 3680045573, 12/case - Shredded, 8 oz., UPC 3680005117, 12/case - Shredded, 16 oz., UPC 3680005144, 12/case - Shredded, 32 oz., tube-style bag, UPC 3680012914, 6/case, case UPC 3680041215 - Shredded, 32 oz., square-style bag, UPC 3680038305, 6/case 9) Food Lion - Shredded, 8 oz., UPC 3582609008, 12/case 10) Gold Rush Creamery - Shredded, 8 oz., UPC 1401401014, 12/case - Shredded, 32 oz., UPC 1401401030, 6/case 11) Good & Gather - Fine Cut, 8 oz., UPC 8523903860, 12/case - Classic, 8 oz., UPC 8523903849, 12/case - Classic, 32 oz., UPC 8523903852, 6/case 12) Great Lakes Cheese - Shredded, 5 lb., UPC 3651415034, 4/case 13) Great Value - Finely Shredded, 8 oz., UPC 7874237425, 6/case - Finely Shredded, 16 oz., UPC 7874204492, 5/case - Shredded, 8 oz., UPC 7874235317, 6/case - Shredded, 16 oz., UPC 7874235321, 5/case - Shredded, 32 oz., UPC 7874237475, 6/case - Shredded, 5 lb., UPC 7874204980, 4/case 14) Happy Farms by Aldi - Shredded, 16 oz., UPC 4061463330864, 12/case - Shredded, 32 oz., UPC 4061463369413, 8/case 15) H-E-B - Shredded, 8 oz., UPC 4122022272, 12/case - Thick, 8 oz., UPC 4122061295, 12/case - Shredded/Fancy Finamente Rallado, 8 oz., UPC 4122006759, 12/case (distributed for sale in Mexico only) 16) Hill Country Fare - Shredded, 8 oz., UPC 4122018977, 12/case - Shredded, 16 oz., UPC 4122016234, 12/case - Shredded, 32 oz., UPC 4122042334, 6/case - Shredded, 5 lb., UPC 4122082998, 4/case - Shredded/Rallado, 8 oz., UPC 4122024512, 12/case (distributed for sale in Mexico only) 17) Know & Love - Fine Cut, 8 oz., UPC 788030650, 12/case - Fine Cut, 16 oz., UPC 788030657, 12/case - Classic Cut, 8 oz., UPC 788030659, 12/case - Classic Cut, 32 oz., UPC 788030658, 6/case - Thick Cut, 8 oz., UPC 788030678, 12/case 18) Laura Lynn - Finely Shredded, 8 oz., UPC 8685401031, 12/case - Shredded, 8 oz., UPC 8685400824, 12/case - Shredded, 12 oz., UPC 8685400815, 12/case - Shredded, 16 oz., UPC 8685406528, 12/case - Thick Cut Shredded, 8 oz., UPC 8685407109, 12/case 19) Lucerne Dairy Farms - Finely Shredded, 8 oz., UPC 2113004867, 12/case - Shredded, 8 oz., UPC 2113004259, 12/case - Shredded Family Size, 32 oz., UPC 2113004741, 6/case - Rustic Cut, 8 oz., UPC 2113004944, 12/case - Rustic Cut Family Size, 32 oz., UPC 2113004949, 6/case 20) Nu Farm - Fancy Shredded, 8 oz., UPC 3104100151, 12/case 21) Publix - Shredded, 8 oz., UPC 4141511665, 12/case - Shredded, 16 oz., UPC 4141523365, 12/case 22) Schnuck's - Shredded, 8 oz., UPC 4131858010, 12/case 23) Simply Go - Classic Cut Shredded, 8 oz., UPC 1015983021, 12/case - Classic Cut Shredded, 32 oz., UPC 1015983020, 6/case - Rustic Cut Shredded, 8 oz., UPC 1015983040, 12/case 24) Sprouts Farmers Market - Finely Shredded, 8 oz., UPC 4667052284, 12/case - Shredded Value Pack, 32 oz., UPC 4667052279, 6/case 25) Stater Bros. Markets - Finely Shredded, 8 oz., UPC 7417546413, 12/case - Shredded, 8 oz., UPC 7417546402, 12/case - Shredded, 32 oz., UPC 7417546435, 6/case 26) Sunnyside Farms - Shredded, 16 oz., UPC 1754450204, 5/case - Shredded, 32 oz., UPC 1754450057, 12/case
Potential metal fragments from supplier raw material (downstream recall)
Class II
Blonde Beard's Dojo Asian Wing Sauce, wing sauce hot sauce condiment, shelf stable, 2 years, glass bottle, 8 oz, Blonde Beard s. Responsible firm on label: Blonde Beard s 2230 S Braun Ct Lakewood, CO 80228.
Undeclared Soy
Blonde Beard'sfood
Class I — Urgent
Genepro Whey 4th Generation Plasma Treated Protein, unflavored, Net Wt. 225g, 30 servings, packaged in a resealable mylar bag, UPC 850053365126, Manufactured For: Genepro Protein, Inc. 15000 Weston Parkway, Cary NC 27513 Front label reads, in part: "* LACTOSE FREE * DAIRY FREE *ALLERGEN FREE" Back label reads, in part: "OTHER INGREDIENTS: Hydrolyzed NiHPRO ProteinIsolate (Pea Protein Isolate, Rice Protein Isolate, Mungbean Protein Isolate, L-Lysine, L-Leucine, L-Threonine, L-Methionine). CONTAINS: Pea, Rice
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
Class II
Costco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
Class II
Publix Deli Carolina-Style Mustard BBQ Sauce; 96- 2OZ NET WT: 12 LB SKU: 10 026700 16964 6
foreign objects (black plastic planting material) in granulated onion
Class II
Mozzarella and provolone shredded cheese blend (containing low-moisture part-skim mozzarella and not-smoked provolone cheeses), individually packaged in a plastic bag, as: 1) Freedom's Choice Pizza Blend - Fine-Cut, 32 oz., UPC 4279810410, 6/case 2) Good & Gather Mozzarella & Provolone - Classic, 8 oz., UPC 8523903871, 12/case 3) Great Lakes Cheese Mozzarella & Provolone - Shredded, 5 lb., UPC 3651415115, 4/case 4) Great Value Provolone & Mozzarella Blend - Shredded, 16 oz., UPC 7874226743, 5/case
Potential metal fragments from supplier raw material (downstream recall)
Class II
My Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottle with a white cap; bottle size is 150 CC; the net contents in 60 clear capsules containing brown powder
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
Water Pure, Inc.food
Class II
Italian Salad Dressing; Net 1 GAL (3.78L) SKU: 7 67367 00518 4 Creamy Poblano Avocado Ranch Dressing and Dip; Net Contents 1 GAL93.78L) SKU: 7 34730 53243 1 Ventura Caesar Dressing; Net WT 2000LB (907.1kg) SKU: 00 026700 17360 8 Pepper Mill Regal Caesar Dressing; 1 GAL (128 FL OZ) 3.79 L SKU: 0 93901 72607 0 Pepper Mill Creamy Caesar Dressing; 1 GAL (128 FL OZ) 3.79 L SKU: 0 93901 78134 5 Ceasar Dressing (Costco Service Deli) NET WT: 23.62 LB (10.71 kg) SKU: 0 26700 19376 7 Ceasar Dressing (Costco Food Court) NET WT: 32 LB (14.51 kg) SKU: 0 26700 19376 7 Hidden Valley, Buttermilk Ranch; NET 1 GAL (3.79L) SKU: 0 26700 19192 3
foreign objects (black plastic planting material) in granulated onion
Class II
Lava Bun with Salted Egg Yolk orange packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
Class II
Good & Gather Mozzarella & Parmesan shredded cheese blend, Fine Cut, 8 oz., individually packaged in a plastic bag, UPC 8523903856, 12/case
Potential metal fragments from supplier raw material (downstream recall)
Class II
Lava Bun with Green Tea Flavor bright lime green packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
Class II
Italian style shredded cheese blend (containing low-moisture part-skim mozzarella, provolone, parmesan, romano, fontina and asiago cheese), individually packaged in a plastic bag, as: 1) Brookshire's Italian 6-Cheese - Finely Shredded, 8 oz., UPC 9282510174, 12/case 2) Cache Valley Creamery Six Cheese Italian - Finely Shredded, 8 oz., UPC 7495800257, 12/case 3) Coburn Farms Italian Style - Finely Shredded, 12 oz., UPC 5193365638, 18/case 4) Great Value Italian Style - Finely Shredded, 8 oz., UPC 7874201566, 6/case - Finely Shredded, 16 oz., UPC 7874203979, 5/case 5) Know & Love Italian Style - Fine Cut, 8 oz., UPC 788030645, 12/case 6) Laura Lynn Italian Blend - Finely Shredded, 8 oz., UPC 8685405157, 12/case 7) Publix Italian Six Cheese Blend - Fancy Shredded, 8 oz., UPC 4141518065, 12/case 8) Simply Go Italian Style Six Cheese Blend - Fine Cut Shredded, 8 oz., UPC 1015983015, 12/case
Potential metal fragments from supplier raw material (downstream recall)
Class II
Pizza style shredded cheese blend (containing low-moisture part-skim mozzarella and mild cheddar cheeses), individually packaged in a plastic bag as: 1) Econo Pizza - Shredded, 8 oz., UPC 893800297, 12/case 2) Food Club Pizza Style Two Cheese Blend - Finely Shredded, 8 oz., UPC 3680012422, 12/case - Shredded, 32 oz., square-style bag, UPC 3680044487, 6/case - Shredded, 32 oz., tube-style bag, UPC 3680048197, 6/case 3) Gold Rush Creamery Pizza Blend - Shredded, 32 oz., UPC 1401401030, 6/case 4) Great Value Pizza Blend - Shredded, 8 oz., UPC 538818789, 6/case 5) Laura Lynn Pizza Blend - Finely Shredded, 8 oz., UPC 8685402132, 12/case 6) Simply Go Pizza Blend Two Cheese Mix - Classic Cut Shredded, 32 oz., UPC 1015983022, 6/case
Potential metal fragments from supplier raw material (downstream recall)
Class II
Costco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
Class II
Food Club Finely Shredded Pizza Style Four Cheese Blend (containing low-moisture part-skim mozzarella, not-smoked provolone, parmesan & romano cheeses), 8 oz., packaged individually in a plastic bag, UPC 3680017231, 12/case
Potential metal fragments from supplier raw material (downstream recall)
Class I — Urgent
Whatcom Blue Sliced cheese; Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.
Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels.
Class II
Jeni's Passion Fruit Dreamsicle Ice Cream Bars, 3 FL OZ (89 ML)/9 FL OZ (266 ML), packaged 3 bars per retail carton with Item UPC: 850060644122, packed 8 retail cartons per case with Case UPC: 10850060644129
Undeclared allergens - wheat and soy
Class I — Urgent
Whatcom Farmhouse- Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.
Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels.
Class II
DEVI brand Cinnamon Powder (Dalchini Powder), net wt.: 3.5 oz (100 g), packaged in flexible plastic bag. UPC 6 09595 11904 5. Imported and Distributed by Homeneeds Inc. Bellevue, WA 98007; Product of India
Elevated levels of lead. FDA ground cinnamon sample was found to contain 2.92 mg/kg.
Homeneeds Incfood
Class I — Urgent
Twin Sisters Creamery Whatcom Blue cheese, 2.5lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made in Ferndale, WA. www.twinsisterscreamery.com.
Raw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.
Class I — Urgent
Item# 29608 Farmhouse White, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters Creamery in Ferndale, WA. Distributed by Peterson Company of Auburn, WA.
Item #29608 Farmhouse White is recalled due to E. coli O103:H2.
Class I — Urgent
Twin Sisters Creamery Mustard Seed cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: Cultured raw cow's milk, salt, whole yellow mustard seeds and enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.
Raw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25.
Class I — Urgent
Twin Sisters Creamery Farmhouse Cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, and enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.
Raw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25.
Class I — Urgent
Item# 28855 Whatcom Blue, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. There are 16 pieces per case. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters Creamery in Ferndale, WA. Distributed by Peterson Company of Auburn, WA.
Item #28855 Whatcom Blue is recalled due to E. coli O103:H2
Class I — Urgent
Twin Sisters Creamery Peppercorn cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, whole peppercorns, salt, enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.
Raw milk Peppercorn cheese is recalled due to E.coli O26:H11
Class I — Urgent
Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea. The label of recalled product declared: Ingredients: Cone snack, Strawberry syrup, Biscuit, Chocolate spray, Topping Chocolate, Ice cream mix (Sugar, Mixed milk powder, Processed Butter, Processed oligosaccharide, Mixed formulation, Natural vanilla flavor, synthetic vanilla flavor, water) CONTAIN: Milk.
Undeclared peanut.
Class I — Urgent
Peach Salsa - $5.99-16 oz 639123940636 packaged in clear plastic clamshells Sell by 11/3/2025 Sell by 11/4/2025
Peaches provided by Moonlight Peaches potentially contaminated with Listeria.
Class II
Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248
Products contains Magnesium Salicylate.
Class I — Urgent
Peach Salsa; UPC 85006540364 14oz (397g); Use by 10/12/2025 to 10/29/2025
Peaches provided by Moonlight Peaches potentially contaminated with Listeria.
Class II
Product Name: Total Comfort. Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 60, Dose: 2 Capsules. Product Sku: PB173.
Products contains Magnesium Salicylate.
Class I — Urgent
Monarch Premium Kratom Green Maeng Da powder is packaged in seal mylar pouches: Monarch Premium Kratom Green Maeng Da, 4oz powder (112g), UPC 851006008466 Monarch Premium Kratom Green Maeng Da, 0.5oz powder (14g), UPC 851006008770 Monarch Premium Kratom Green Maeng Da, 2oz powder (56g), UPC 851006008459
Product has the potential to be contaminated with Salmonella
Class I — Urgent
Monarch Premium Kratom White Elephant powder is packaged in seal mylar pouches: Monarch Premium Kratom, White Elephant, 4oz powder (112g), UPC 851006008480 Monarch Premium Kratom, White Elephant, 0.5oz powder (14g), UPC 851006008756 Monarch Premium Kratom, White Elephant, 8oz powder (224g), UPC 706970483644
Product has the potential to be contaminated with Salmonella
Class II
Product Name: Tense-X. Package: 175cc HDPE Bottle. Type: Vegetable Capsule. Count: 60. Dose: 2 Capsules. Product Sku: PB207
Products contains Magnesium Salicylate.
Class I — Urgent
Monarch Premium Kratom Red Bali powder is packaged in seal mylar pouches: Monarch Premium Kratom Red Bali, 4oz powder (112g), UPC 851006008442 Monarch Premium Kratom Red Bali, 8oz powder (224g), UPC 706970483859 Monarch Premium Kratom Red Bali, 2oz powder (56g), UPC 851006008435
Product has the potential to be contaminated with Salmonella
Class I — Urgent
Monarch Premium Kratom Bali Gold powder is packaged in seal mylar pouches: Monarch Premium Kratom Bali Gold, 4oz powder (112g), UPC 851006008428 Monarch Premium Kratom Bali Gold, 8oz powder (224g), UPC 706970483712
Product has the potential to be contaminated with Salmonella
Class II
Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp, net wt. 2lbs. UPC 011110626196. Product is packaged in clear plastic bag and has a white label with green stripes on top of each bag.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lbs. UPC 731149654075. Product was sold at WinCo.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net wt. 2lbs., UPC 021130123223. Product was sold at Shaw s and Star Market, Albertson's, Eagle, Carrs-Safeway, and Safeway.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
AquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs. UPC 731149654051. Product was sold at Publix.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
Bakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory, #10 Graham Pieces, Distributed by Ice Cream Factory, 1201 Ice Cream Way, Lebanon, MO 65536"
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
Class II
Publix Large Shrimp Peeled & Deveined Tail On 31/40, net wt. 1.5 lbs. UPC 041415067455. Product was sold at Publix.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
Publix Extra Large Shrimp Easy to Peel Deveined 21/25, net wt. 1.5 lbs. UPC 041415064454. Product was sold at Publix.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
AquaStar Raw Peeled Tail-on Shrimp Skewers, net wt. 1.25lbs. UPC 731149390010. Product is packaged in a printed bag with a black top and blue bottom and printed pictures of the skewers inside.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
Kroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011110643906. Product is packaged in transparent printed bag with a blue band on the top with yellow and red details.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
Strawberry Cheesecake Ice Cream with graham crackers swirl, 12 oz pack, Single Cup Net Wt: 8.75oz, Case of 12 Strawberry Cheesecake with graham cracker swirl, 2.5-gal Tub, Net Weight 14 pounds Labels read in part as "Ice Cream Factory, Distributed by Ice Cream Factory 1201 Ice Cream Way, Lebanon, MO 65536"
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
Class II
Best Yet Frozen Raw EZ-Peel White Shrimp 16/20 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700282 Best Yet Frozen Raw EZ-Peel White Shrimp 21/25 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700286 Best Yet Frozen Raw EZ-Peel White Shrimp 26/30 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700283 Best Yet Frozen Raw EZ-Peel White Shrimp 31/40 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700287 Best Yet Frozen Raw EZ-Peel White Shrimp 41/50 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700284 Best Yet Frozen Raw EZ-Peel White Shrimp 51/60 (net wt. 1 lbs/pkg; 10 pkgs per case).UPC 04218700288 Best Yet brand product was distributed by C&S Wholesale.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class I — Urgent
White Chocolate Coconut Bundt Cake - Net Weight 3 lbs 12 oz Contains: Wheat, Soy, Milk, Eggs No UPC
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Class I — Urgent
Carrot Bundt Cake - Net Weight 4 lbs Contains: Wheat, Soy, Milk, Eggs, Tree Nuts No UPC
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Class II
Deli Express BBQ Pulled Pork on a sesame bun. Net Wt 5.5oz (156g) UPC 0 41433-03087 5. EA Sween Company, Eden Prairie, MN 55344.
Potential foreign material (plastic)
E.A. Sween Co.food
Class I — Urgent
Fresh Creative Foods (FCF) item #404637 Basil Pesto Bowtie Pasta Kit Item V, UPC#13454 38053. Perishable/Refrigerated product. Net wt. 10.5625lbs. This kit contains 2/3lbs. sealed bags of affected Bowtie Pasta, and it is not sold directly to consumers.
Salad Kits are recalled due to potential contamination with Listeria monocytogenes.
Class II
Tovala branded Frozen raw phosphate free shrimp; 5oz IQF bag UPC: 829944085788
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Class I — Urgent
Egg and Cheese Breakfast Burrito; 3.75 oz; 72 count/case; UPC# 1 070657 477333 9 RTE Egg and Cheese Breakfast Wrap; 2.50 oz; 72 count/case; UPC# 1 070657 497861 1
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Class I — Urgent
Sprouts Smoked Mozzarella Pasta Salad, RTE Pasta Salad, Refrigerated, 5 day shelf life, packaged into plastic containers at Deli counter and into 16oz plastic grab & go containers, weight dependent on customer request, UPC 2-15587-00000 (from service case) and 2-15786-00000 (from Grab & Go), Sprouts Farmers Market 5455 E High St., Suite 111 Phoenix, AZ 85054.
Product may contain Listeria monocytogenes.
Class I — Urgent
Fresh Creative Foods (FCF) item #404736 Basil Pesto Bowtie Pasta Kit, UPC #13454 38092. Perishable/Refrigerated product. Net wt. 10.3125lbs. This kit contains 2/3lb. sealed bags of affected Bowtie Pasta and does not contain spinach. Kit is not sold directly to consumers.
Salad Kits are recalled due to potential contamination with Listeria monocytogenes.
Class I — Urgent
Fresh Creative Foods (FCF) item #404284 Smoked Mozzarella Penne Salad Kit, UPC #13454 37904. Perishable/Refrigerated product. Net wt. 13lbs. This kit contains 2/3lbs. sealed bag of affected Penne Pasta and kit is not sold directly to consumers.
Salad Kits are recalled due to potential contamination with Listeria monocytogenes.
Class II
Arctic Shores; Best Yet; Great American; Master Catch branded Frozen Raw shrimp; 2lbs; 1lbs; UPC: 041130810923; 041512179471; 041130810978; 041130811029; 011110641182; 829944010636; 041130811333; 041130810916; 041130812460; 041130810824; 829944012463; 829944012012; 829944004079; 829944095060; 829944076984; 011110641168; 829944094537; 829944010612; 829944013583; 041512179471 011110643902; 041130811357;
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Class II
Arctic Shores branded Frozen cooked salad shrimp; 6 oz bag UPC: 041130811685
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Class I — Urgent
Basil Pesto Bowtie Pasta Salad, packaged in plastic containers with various weights, with UPC 217573-1XXXX (sold at deli service counters) or UPC 217573-2XXXX (sold as Grab-n-Go packages in deli departments), under the banners Kroger, Baker's, City Market, Dillons, Fred Meyer, Fry's, Gerbes, King Soopers, Payless, Ralphs and Smith's
Store-made deli items contain a pasta ingredient that was recalled due to potential Listeria monocytogenes
The Kroger Cofood
Class I — Urgent
Smoked Mozzarella Penne Salad, packaged in plastic containers with various weights, with UPC 227573-1XXXX (sold at deli service counters) or UPC 227573-2XXXX (sold as Grab-n-Go packages in deli departments), under the banners Kroger, Baker's, City Market, Dillons, Fred Meyer, Fry's, Gerbes, King Soopers, Payless, Ralphs and Smith's
Store-made deli items contain a pasta ingredient that was recalled due to potential Listeria monocytogenes
The Kroger Cofood
Class II
Great American branded Frozen raw shrimp skewer; 1lb bag UPC: 829944002716; 829944002372
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Class II
Rolling Pin brand Dubai Style Chocolate; 17.64 oz stand up pouch; Ingredients: Sugar, Cocoa Butter, Vegetable Fats, Whole Milk Powder, Pistachio (Tree Nut), Skimmed Milk Powder, Cocoa Mass, Kunefa, Soy Lecithin, Natural Vanilla Powder; Allergens: Contains Milk, Soy, Nuts (Pistachio), Gluten; Product of Belgium, Spain, USA, or Canada; Distributed & Imported by Rolling Pin Baking Company LLC; UPC # 642461215854
Product does not declare wheat in the allergen statement.
Class I — Urgent
Cheese and Egg with Green Salsa Breakfast Burrito; 3.75 oz; 72 count/case; UPC# 1 070657 468334 8
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Class II
Arctic Shores; Best Yet; Great American; Master Catch branded Frozen cooked shrimp; 2lbs; 1lbs; 12oz bags; UPC: 041130810497; 041130810411; 041130811685; 041130810817; 042187002705; 829944012623; 042187002712; 829944012630; 042187002729; 829944011510; 041130812385; 042187002736; 042187002736; 829944013576; 829944012616; 829944093073; 041130810466; 041130810473; 042187002743; 829944011541; 717544137047; 829944012173; 829944002631; 042187002750; 829944011565; 829944010674; 829944011381; 042187002774; 829944092540; 041130812392
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Class II
Oceans Kitchen IMITATION CRABMEAT SHREDDED Made From Wild Fish, Refrigerated, vacuum package. Net wt. per bag 2.5 lbs. UPC 1 90456 75654 2. These 2.5lb. bags are not for retail sales. Each master case contains 12/2.5lbs. bags. Net wt. per case: 30lbs. UPC 14972195756549. Oceans Kitchen Corporation, 7622 S 188TH ST., KENT, WA 98032
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm.
Class I — Urgent
Scott & Jon s Shrimp Scampi with Linguine, 9.6 oz.
Contains Linguine manufactured by Nate's Fine Foods LLC recalled for Listeria monocytogenes and implicated in ongoing outbreak
Class II
6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGANIC APPLES, ORGANIC SPINACH, WATER, ORGANIC LEMON JUICE. Dist. by Sprout Foods, Inc. Montvale, NJ 07645 UPC: 818512011762
Potential contamination with heavy metal (Lead).
Class I — Urgent
Haifa COLD SMOKED SALMON 8 OZ.
Contaminated with Listeria monocytogenes
Class II
Halved Pears IN PEAR JUICE FROM CONCNETRATE; NET WT 15 OZ (425 g); Ingredients: Pears, Water, Pear Juice Concentrate; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603
Potential contamination with heavy metal (Lead).
Class I — Urgent
Sliced (1/4") green onions, refrigerated, packaged in plastic bag. Each case consist 5/6lbs. bag (net wt. 30lbs.). Garden Fresh Foods Inc. Woodinville, WA. Product is distributed in bulk package and is not sold directly to consumers.
Possible positive Listeria monocytogenes. Firm tested one lot of sliced green onions in-house and found Listeria monocytogenes.
Class II
Fruit Cocktail IN 100% JUICE WITH ADDED INGREDIENTS; NET WT 15 OZ (425 g); Ingredients: Diced Peaches, Diced Pears, Water, Grapes, Peach Pulp and Juice, Pineapple Sectors, Pear Juice Concentrate, Halved Cherries (colored red with Carmine), Ascorbic Acid (to protect color).; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603
Potential contamination with heavy metal (Lead).
Class II
Sea Port brand, Raw Frozen Easy Peel Headless Shell-On White Shrimp, Jumbo size 16-20. Product of Indonesia. Distributed by Sea Port Products Corporation, Kirkland, WA. Master Case: 10/2 lbs. bags. Net weight 20lbs. UPC 10659878008617 IQF Inner Bag 2lbs: UPC 6 59878 00861 0 Sea Port brand, Raw Frozen Easy Peel Headless Shell-On White Shrimp, Jumbo size 16-20. Product of Indonesia. Distributed by Sea Port Products Corporation, Kirkland, WA. Master Case: 20/1 lbs. bags. Net weight 20 lbs. UPC 10659878010016 IQF Inner Bag 1lbs: UPC 6 59878 01001 9
Shrimp may be contaminated with Cesium-137 (Cs-137).
Class II
Pears Halves in Pear Juice from Concentrate; NET WT 15 OZ (425 g); Ingredients: Pears, Water, Pear Juice Concentrate; Distributed By: Walmart Inc., Bentonville, AR 72716
Potential contamination with heavy metal (Lead).
Class II
Pears SLICED in Organic Pear Juice from Concentrate; NET WT 15 OZ (425 g); Ingredients: Organic Pears, Water, Organic Pear Juice Concentrate; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603
Potential contamination with heavy metal (Lead).
Class I — Urgent
Haifa COLD SMOKED SEABASS 8 OZ
Contaminated with Listeria monocytogenes
Class II
Good and Gather brand Southwest-Style Burrito Bowl Blend Processed in a facility that also handles shellfish, egg, fish, milk, sesame, soy, tree nut and wheat ingredients
Product may contain undeclared shrimp (crustacean shellfish).
ONE FROZEN, LLCfood
Class II
NOW Real Food Organic Unsalted Whole Raw Cashews, 10 oz. pouch, UPC 7 33739 07066 1 Product Code 7066
Undeclared pine nut
Now Foodsfood
Class I — Urgent
Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193, net wt. 1lb. Product is packaged in clear plastic clamshell container and sold to consumers.
Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.
Class III
Scott & Jon s Honey Sesame Salmon Rice Bowl
contains undeclared wheat
Class II
Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. UPC: 011110624840
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Class II
16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised Shrimp; 32oz clear plastic retail bag. UPC: 011110967015
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Class I — Urgent
GOODLES HERE COMES TRUFFLE CREAMY TRUFFLE FLAVORED CHEDDAR AND SHELLS NET WT 6 OZ (170g) INGREDIENTS: GOODLES SHELLS (WHEAT FLOUR, CHICKPEA PROTEIN, WHEAT PROTEIN, NUTRIENTS EXTRACTED FROM [BROCCOLI, SPINACH, KALE, PUMPKIN, SWEET POTATO, SUNFLOWER SEED, CRANBERRY, CHLORELLA, MAITAKE MUSHROOM, SHIITAKE MUSHROOM]), CHEDDAR AND PARMESAN CHEESES (CULTURED MILK, SALT, DISODIUM PHOSPHATE, ENZYMES), WHEY, NATURAL FLAVOR, BUTTER (CREAM, SALT), NONFAT DRY MILK, SALT, TAPIOCA FLOUR, NUTRITIONAL YEAST, LACTIC ACID, PORCINI MUSHROOMS, BLACK PEPPER, PAPRIKA, GROUND BALCK TRUFFLES. CONTAINS WHEAT AND MILK Distributed by Gooder Foods Inc. Santa Cruz, CA 95060
Undeclared allergens (cashews).
Class I — Urgent
GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SPIRALS NET WT 5.25 OZ (149g) INGREDIENTS: GOODLES SPIRALS (WHEAT FLOUR, CHICKPEA PROTEIN, WHEAT PROTEIN, NUTRIENTS EXTRACTED FROM [BROCCOLI, SPINACH, KALE, PUMPKIN, SWEET POTATO, SUNFLOWER SEED, CRANBERRY, CHLORELLA, MAITAKE MUSHROOM, SHIITAKE MUSHROOM]), VEGAN WHITE CHEDDAR CHEESE (DRIED CASHEW MILK [CASHEWS, CHICORY ROOT FIBER], NATURAL FLAVOR, NUTRITIONAL YEAST, TAPIOCA FLOUR, PEA PROTEIN, LACTIC ACID, DRIED APPLE CIDER VINEGAR, GARLIC). CONTAINS WHEAT AND CASHEWS Distributed by Gooder Foods Inc. Santa Cruz, CA 95060
Undeclared allergens (milk).
Class III
PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT UPC 6 89466 70601 7 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class II
Frozen AquaStar Breaded Shrimp, Butterfly, Clean-Tail, 16/20 count/lb. 3 lbs. package. Net wt. per case 36lbs. (12x3lbs. packages per case). UPC 731149601192. Packed For: AquaStar Seattle, WA. Farm Raised Product of Indonesia.
Product may be contaminated with Cesium-137 (Cs-137).
Class III
HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR OVERALL CARDIOVASCULAR HEALTH HELPS MAINTAIN HEALTHY CHOLESTEROL LEVELS ALREADY WITHIN THE NORMAL RANGE SUPPORTS PROSTATE AND IMMUNE HEALTH 90 TABLETS UPC 8 11836 02587 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class II
Best Yet; Arctic Shores; and Great American branded Frozen cooked shrimp; 1 Pound/ 12 OZ/ 6 OZ/ 2 Pound plastic bag; (Various Brands) UPC#: 042187002736; 042187002743; 041130812392; 041130810497; 041130810411; 041130811685; 829944092540; 829944012173
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Class III
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
Class II
Frozen Mercado Kroger Cooked Shrimp - Medium - Peeled - Tail-Off - Shrimp Pieces. 2 lbs. package. Net wt. per case 10lbs. (5x2lb packages per case). UPC 011110626196.
Product may be contaminated with Cesium-137 (Cs-137).
Class II
AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. Master cases distributed to distributors in frozen condition. AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce, net wt. 6oz. UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. 6oz packages sold to consumers at Walmart as refrigerated product.
Product may be contaminated with Cesium-137 (Cs-137).
Class I — Urgent
NEUHAUS brand ORIGINAL BELGIAN CHOCOLATE; POPPING MILK CHOCOLATES WITH COOKIES; 4.23 oz - 120g; (EN)Chocolates - INGREDIENTS: milk chocolate (sugar, whole milk powder, cocoa mass, cocoa butter, emulsifier: soy lecithin, flavour), sugar, sunflower oil, whole milk powder, cocoa butter, skimmed milk powder, carmelised sugar, cocoa mass, glucose syrup, emulsifier: soy lecithin, spices, lactose, flavours, acidity regululator: malic acid; carbon dioxide. May contain traces of eggs, sesame, groundnuts and nuts
Product contains undeclared wheat.
Neuhaus nvfood
Class III
Top Secret Nutrition extra strength uric control fast acting multi-pronged uric acid control 30 veggie caps DIETARY SUPPLEMENT UPC 8 11226 02158 4 Distributed by: TOP SECRET NUTRITION, LLC 6015-B Unity Dr. Norcross, GA 30052
Unapproved Drug Claims.
Class III
HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH FIGHTS OXIDATIVE STRESS 60 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02446 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class III
FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES PROMOTES HEALTH CARTILAGE LUBRICATES JOINTS 240 Capsules UPC 7 97573 90884 1 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
Class III
HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class III
HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION MUSCLE SIZE POWER RECOVERY ENERGY STRENGTH LACTIC ACIDE ELIMINATION LEAN MUSCLE 500 GRAMS NET WT. (17.630OZ) DIETARY SUPPLEMENT UPC 8 11836 02362 6 HI-TECH PHARMECEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
Class II
CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXTRIN, HYDROLYZED CORN PROTEIN, GARLIC POWDER, TURMERIC (COLOR), SPICES, CARROT JUICE CONCENTRATE, CALCIUM SILICATE (ANTICAKING AGENT), CARAMEL COLOR, NATURAL FLAVORS, DISODIUM INOSINATE, DISODIUM GUANYLATE, CITRIC ACID) ***
Undeclared Yellow #5 and Yellow #6.
Class II
Sand Bar; Great American; and First Street branded Frozen raw shrimp; 2 pound plastic bag; UPC#: 011110641182; 829944010612; 041512179471; 829944010698; 8299440106636
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Class III
HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class III
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT PEACH MANGO NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40906 3 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class III
IFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8 54503 00226 5 Manufactured By: iForce Nutrition 6015B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
Class III
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WATERMELON NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40905 6 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class II
CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXTRIN, HYDROLYZED CORN PROTEIN, GARLIC POWDER, TURMERIC (COLOR), SPICES, CARROT JUICE CONCENTRATE, CALCIUM SILICATE (ANTICAKING AGENT), CARAMEL COLOR, NATURAL FLAVORS, DISODIUM INOSINATE, DISODIUM GUANYLATE, CITRIC ACID) ***
Undeclared Yellow #5 and Yellow #6.
Class III
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT KIWI-STRAWBERRY NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 89466 70619 2 Manufactured by: Prime Nutrition 6015-b Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Class III
LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 44890 94151 6 MADE FOR LG SCIENCES 6015-B UNITY DR. NORCROXX, GA 30071
Unapproved Drug Claims.
Class III
HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain Revolutionary Joint Support System 90CT UPC 8 57084 00035 4 Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Dr Norcross, GA 30071
Unapproved Drug Claims.
Class III
HI-TECH PHARMACEUTICALS SLIMAGLUTIDE REVOLUTIONARY WEIGHT LOSS AID WITH GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST AND SECRETAGOGUES NOVEL GIP (GLUCOSE-DEPENDENT ISNULINOTROPIC POLYPEPTIDE) RECEPTOR AGONIST 180 TABLETS DIETARY SUPPLEMENT
Unapproved Drug Claims and Misbranded.
Class III
Anabolic Research WINN-50 (vanazolol). Dietary Supplement. 90 Capsules. UPC 8 51840-00707 6. Manafactured For: Anabolic Research, 6942 FM 1960 E. #346, Humble, TX 77346-2706.
Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
Class I — Urgent
Salad Kit labeled as follows: Taylor FARMS Honey Balsamic SALAD KIT, NET WT. 8.3 OZ (235g), INGREDIENTS: HONEY BALSAMIC VINAIGRETTE (soybean oil ...) SPINACH, CARROT, SEA SALT CROISSANT CROUTON (wheat flour ...) CRUMBLED FETA CHEESE (feta cheese [pasteurized milk ...] ...) MIZUNA, GREEN LEAF LETTUCE, RED LEAF LETTUCE, LOLLA ROSA, GREEN OAK, RADICCHIO. CONTAINS: MILK, WHEAT. Salad Dressing package inside Salad Kit labeled as follows: SESM GNGR
Undeclared allergens (sesame and soy).
Class II
Baker's Authority Three Seed Mix; 5lb bag; stored dry at room temperature; packaged in silver bag
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flax
Class II
Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 oz twin pack UPC 8 88109 01002 7; 10-1.28 oz carton (12.7 oz) UPC 8 88109 11061 1; 16-1.28 oz carton (20.31 oz) Individual selling unit - UPC 8 88109 01182 6 16-count selling unit - UPC 8 88109 11092 5
Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.
Class II
Baker's Authority Everything Bagel Mix; 5lb bag and 1lb bag; stored dry at room temperature; packaged in silver bag
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea salt
Class II
Baker's Authority Graham Cracker Meal; 5lb bag; stored dry at room temperature; packaged in silver bag
Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar
Class II
Sri Sri Tattva, Ojasvita Chocomalt,7oz / 200g, Paper Pouch, 25 packages per case
Product contains undeclared soy lecithin.
SRI SRI TATTVAfood
Class II
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
Product label includes the ingredient CREAM but does not include Milk as the source.
Class III
Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class II
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00163-0, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ROAD, HAYWARD, CA 94545 USA
Potential contamination with foreign objects (metal pieces).
Class II
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072
Potential presence of glass pieces
Class II
Sukhi's TIKKA MASALA CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-105, UPC 7-67226-01005-2, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Potential contamination with foreign objects (metal pieces).
Class III
Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class II
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
foreign material (plastic)
Class II
Sukhi's, CLASSIC CURRY INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00165-4, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ROAD, HAYWARD, CA 94545 USA
Potential contamination with foreign objects (metal pieces).
Class II
La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101, UPC: 7-67226-01001-4, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Potential contamination with foreign objects (metal pieces).
Class III
Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC. UPC#: none
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class II
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
Product label includes the ingredient CREAM but does not include Milk as the source.
Class III
Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class II
Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
Product label includes the ingredient CREAM but does not include Milk as the source.
Class III
Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. UPC#: 717340952714
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Class II
La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
Product label includes the ingredient CREAM but does not include Milk as the source.
Class II
Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182259. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
Product may have small flakes of stainless steel in product.
Class I — Urgent
ARAL FISH; ARAL SILVER VOBLA; WHOLE DRIED, SALTED ROACH FISH EVISCERATED; FISH ROE DRIED; Ingredients: whole eviscerated dried roach fish, caviar may be present, salt.; Distributed by Krasnyi Oktyabr; PERISHABLE KEEP REFRIGERATED AT OR BELOW 40F; PRODUCT OF KAZAKHSTAN
Clostridium botulinum (uneviscerated fish)
Class II
Brand Name: Queen Bee Gardens Whipped Honey Pure. Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182006. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
Product may have small flakes of stainless steel in product.
Class II
Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182358. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
Product may have small flakes of stainless steel in product.
Class I — Urgent
Drycapot cookie, net weight: 1.15 oz UPC#: 4 942737 210191
Undeclare Tree Nuts (almond, macadamia nut)
Class I — Urgent
Newly Weds B61672--BREAD CRUMBS X1-NET WT 35 LBS.
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B6010J BREAD CRUMBS-NET WT 35 LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds E54564-BREADER X5-NET WT 25LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B62262-BREAD CRUMBS X1-NET WT 1200 LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B90737-BREADER X1-NET WT 25LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B6047J-BREAD CRUMBS-NET WT 35 LBS.
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds A60447-PANKO JAPANESE STYLE UNTOASTED BREAD CRUMBS-NET WT 25 LBS.
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B6229J-PIZZA CRISP-NET WT 35LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B61610-BREAD CRUMBS X1-NET WT 45 LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B57569 BREADER X1- NEW WT 25 LBS.
potential Listeria Monocytogenes Contamination
Class II
Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or beverage. 1/64 tsp (a pinch) tastes as sweet as 1 tsp of sugar. Distributed by: NuNaturals, Inc. Eugene, OR 97402.
Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
NuNaturals Incfood
Class I — Urgent
Newly Weds A60647- BREAD CRUMBS X1-NET WT 35 LBS.
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B6AAK3-BREAD CRUMBS X1-NET WT 35LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds B61453-BREAD CRUMBS X1-NET WT 25 LBS
potential Listeria Monocytogenes Contamination
Class II
Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Product is packaged in a plastic bottle with white cap. Ingredient: Organic Stevia Extract. Sprinkle a pinch for the perfect sweetness. Suggested Use: 1/64 tsp tastes as sweet as 1 tsp of sugar. Distributed by: NuNaturals, Inc. Eugene, OR 97402.
Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
NuNaturals Incfood
Class I — Urgent
Lespoir cookie, net weight: 1.41 oz. UPC# 4 942737 200147
Undeclared Milk
Class I — Urgent
Newly Weds B60960-BREAD CRUMBS X1-NET WT 6 LBS
potential Listeria Monocytogenes Contamination
Class I — Urgent
Newly Weds A93060 BREADER X1- NEW WT 40 LBS.
potential Listeria Monocytogenes Contamination
Class II
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 11.4 oz, 8 count (8x1.38 oz 6 pack of cracker sandwiches inside carton. 14X8-Case: 14 - 11.04 Oz Cartons in master carton. UPC 0 44000 88210 5
Undeclared allergens (Peanut) due to mispackaging
Class II
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 55.2 oz, 40 count (40x1.38 oz 6 pack of cracker sandwiches inside carton. 40 - 55.2oz Cartons in master carton. UPC 0 44000 07819 5
Undeclared allergens (Peanut) due to mispackaging
Class II
Ritz Cracker Sandwiches, Variety 20 count variety Pack, (20- Packs of 10 Cheese 1.35 oz Packs and 10 Peanut Butter 1.38 oz Packs) Net Wt. 27.3 oz (20-1.38 oz packet of cracker sandwiches inside cartons of varying sizes). 20-27.3 OZ (Case: 6 - 27.3 Oz Cartons in master carton. UPC 0 44000 08095 2
Undeclared allergens (Peanut) due to mispackaging
Class II
Sushi Wasabi; 5 grams (Ready to eat) Ingredients: Horseradish, Corn Oil, Salt, Water, Citric Acid, Tumeric, FD&C Blue#1 Distributed by: Tokyo Nori U.S.A, City of Industry, CA 91746
Individual consumer size Wasabi mini pack label does not declare allergen ingredient Yellow 5.
Class II
Ritz Peanut Butter Cracker Sandwiches, Net Wt.27.6 oz, 20 count (20x1.38 oz) 6- pack of cracker sandwiches inside cartons. And 6x20(6 - 27.6 oz Cartons) in master carton. UPC 1 00 44000 07584 2
Undeclared allergens (Peanut) due to mispackaging
Class II
YoCrunch Low Fat Yogurt with Toppers, Strawberry with milk chocolate M&Ms minis candies, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00083 2. Multipack containing 4-4 oz. cups UPC 46675-01312 Keep Refrigerated. Distributed by Danone US, LLC, White Plains, NY 10605
Foreign material (plastic pieces)
DANONE US LLCfood
Class II
YoCrunch Lowfat Yogurt with Toppers, Vanilla with milk chocolate M&Ms, Packaged in the following size containers: 1. Single Serve Cup 6 oz (170g) UPC 46675-00079 2. Multipack consisting of 4-4 oz. cups UPC 46675-01351 Keep Refrigerated. Distributed by Danone US, White Plains, NY
Foreign material (plastic pieces)
DANONE US LLCfood
Class II
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Snickers pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00112 2. Multipack containing 4-4 oz. cups UPC 46675-01326 Keep Refrigerated. Distributed by Danone US, LLC, White Plains, NY 10605
Foreign material (plastic pieces)
DANONE US LLCfood
Class II
Little Remedies¿ Honey Cough 4 FL OZ (118 mL)
contaminated with Bacillus cereus and may be spoiled
Class II
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Chocolate Chip Cookie Dough pieces, Multipack containing 4-4 oz. (113g) cups. UPC 46675-01315. Keep Refrigerated. Distributed by Danone US, LLC, White Plains, NY 10605
Foreign material (plastic pieces)
DANONE US LLCfood
Class II
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Twix bar pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 oz. (170g) UPC 46675-00113 2. Multipack containing 4-4 oz. cups UPC 46675-01327 Keep Refrigerated. Distributed by Danone US, LLC, White Plains, NY 10605
Foreign material (plastic pieces)
DANONE US LLCfood
Class II
YoCrunch Lowfat Yogurt with Toppers. Two-product package. Contains 8-6oz (170g) cups of Strawberry Yogurt with milk chocolate M&Ms pieces (cup UPC 46675-00084), and 8-6oz (170g) cups of Strawberry Yogurt with Oreo pieces (cup UPC46675-00083). Two-Pack UPC 46675-02613. Keep Refrigerated. Distributed by Danone US, LLC, White Plains, NY 10605
Foreign material (plastic pieces)
DANONE US LLCfood
Class II
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
Subpotent Drug
Class II
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
Failed tablet specifications.
Class III
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Failed Tablet/Capsule Specifications
Radnostixdrug
Class II
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lack of Assurance of Sterility
Chiesi USA, Inc.drug
Class II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Lack of Assurance of Sterility
Apotex Corp.drug
Class II
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Not Yet Classified
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups.
Class II
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Class II
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class III
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc.drug
Class II
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.
CGMP Deviations
Class II
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
CGMP Deviations
Class II
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
Defective container; inadequately sealed blister packaging.
Class II
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Class II
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class II
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
CGMP Deviations
Class II
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
CGMP Deviations
Class II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
CGMP Deviations
Class II
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Stability Data Does Not Support Expiry Date.
Class II
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
Stability Data Does Not Support Expiry Date.
Class II
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.
CGMP Deviations
Class II
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02
CGMP Deviations
Class I — Urgent
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Mohamed Hagardrug
Class II
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.
CGMP Deviations
Class II
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
CGMP Deviations
Class II
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Stability Data Does Not Support Expiry Date.
Class II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
CGMP Deviations
Class II
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
CGMP Deviations
Class II
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
CGMP Deviations
Class II
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Failed Dissolution Specifications
Class II
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
CGMP Deviations
Class II
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01
CGMP Deviations
Class II
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.
CGMP Deviations
Class II
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1
CGMP Deviations
Class II
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Class III
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc.drug
Class II
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Failed Dissolution Specifications
Class II
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Presence of Particulate Matter: Due to production issues
Radnostixdrug
Class II
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Failed Dissolution Specifications
Class II
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
CGMP Deviations
Class II
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
Failed Dissolution Specifications
Class II
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
CGMP Deviations
Class II
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
CGMP Deviations
Class II
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta
CGMP Deviations
Class II
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Failed Dissolution Specifications
Class II
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
CGMP Deviations
Class I — Urgent
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Class II
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class III
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Class II
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
AvKAREdrug
Class II
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
LEO PHARMA INCdrug
Class II
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Ageboxdrug
Class II
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Ageboxdrug
Class II
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class I — Urgent
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
McKessondrug
Class II
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
cGMP deviations
Class II
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Lack of Assurance of Sterility
Class II
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Lack of Assurance of Sterility
Class II
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Class II
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Lack of Assurance of Sterility
Class II
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Lack of Assurance of Sterility
Class II
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class III
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
Tablets/Capsules Imprinted with Wrong ID
Class II
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
Lack of Assurance of Sterility
Class II
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Defective Delivery System: Missing or duplicated needles within the injection kit
Class II
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11
cGMP deviations
Class II
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Presence of Foreign substance - potential presence of metal particulate matter
Class II
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class I — Urgent
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Class II
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Presence of Foreign Tablets/Capsules
Class II
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Class III
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class II
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class III
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72
Failed Impurities/Degradation Specifications
Class II
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Greenstone Llcdrug
Class III
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Failed PH Specifications
Cipla USA, Inc.drug
Class II
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Class II
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Presence of Foreign Substance
Class II
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
Subpotent Drug
Class II
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
LIQUID DAYQUIL 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
EXCEDRIN MIGRAINE 2'S- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Swan, White Clear Alcohol, 50%, 16oz, 12 count
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Aleve 1's, 60 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
MOTRIN 2'S DISP.- 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
EXCEDRIN 2'S DISP.- 30 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class III
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class II
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
PEPTO BISMOL 32CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
cGMP deviations.
Class II
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Presence of Particulate Matter.
Cipla USA, Inc.drug
Class II
NYQUIL COLD & FLU -32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Claritin, 20 Count, UPC: 655708016305
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Alvogen, Incdrug
Class II
Bayer 2Pk- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
PEPCID COMPLETE - 25CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
DAYQUIL COLD & FLU, 32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Benadryl, 25'S 2PK Box, UPC 815556020316
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class III
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class I — Urgent
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLCdrug
Class II
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
Presence of particulate matter - Glass like particles.
Class I — Urgent
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLCdrug
Class II
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Out of specification for dissolution.
AvKAREdrug
Class III
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class II
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Presence of particulate matter - Glass like particles.
Class II
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Presence of particulate matter - Glass like particles.
Class III
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Lack of Assurance of Sterlity
Class II
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03
Presence of particulate matter: potential presence of metal particulates in the product.
Class II
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.
Presence of particulate matter: potential presence of metal particulates in the product.
Class II
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Presence of Foreign Tablets/Capsules
Class II
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
SUN PHARMA /TAROdrug
Class III
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Subpotent product:out of specification assay results observed during long term stability testing.
Class II
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
Defective container: cracked/broken cartridges
Class II
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.
Defective container: cracked/broken cartridges
Class II
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Defective container: cracked/broken cartridges
Class III
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
Subpotent product:out of specification assay results observed during long term stability testing.
Class II
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Defective container: cracked/broken cartridges
Class II
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
Defective container: cracked/broken cartridges
Class III
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
Subpotent product:out of specification assay results observed during long term stability testing.
Class II
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.
Defective container: cracked/broken cartridges
Class II
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.
Defective container: cracked/broken cartridges
Class II
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Failed stability specifications: Out of specification for hardness test
Cipla USA, Inc.drug
Class III
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class III
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Defective container - seal not adhering to bottles
Class II
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc.drug
Class II
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc.drug
Class II
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Failed stability specifications: Out of specification for hardness test
Cipla USA, Inc.drug
Class II
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc.drug
Class III
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Cross Contamination with Other Products
Class II
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Incorrect Product Formulation
Class III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
cGMP deviations
Class II
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
cGMP deviations
Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
cGMP deviations
Class II
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
cGMP deviations
Class II
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
cGMP deviations
Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
cGMP deviations
Class III
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Defective Container - A defect in the side-seal which allows leakage of product.
Class II
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
cGMP deviations
Class II
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Failed Stability Specifications: Observed OOS results: eg results for colour index
Cipla Limiteddrug
Class II
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
cGMP deviations
Class II
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
cGMP deviations
Class II
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
cGMP deviations
Class II
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
cGMP deviations
Class II
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
cGMP deviations
Class II
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
cGMP deviations
Class II
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
CGMP Deviations
Class II
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
CGMP Deviations
Class II
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
CGMP Deviations
Class II
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
CGMP Deviations
Class I — Urgent
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
CGMP Deviations
Class II
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
CGMP Deviations
Class II
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
CGMP Deviations
Class II
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
CGMP Deviations
Class II
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02
CGMP Deviations
Class II
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
CGMP Deviations
Class II
Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
CGMP Deviations
Class II
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17
CGMP Deviations
Class II
Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1
CGMP Deviations
Class II
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class II
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
CGMP Deviations
Class II
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
Failed Dissolution Specifications
Class II
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I — Urgent
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class II
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I — Urgent
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class II
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class II
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class III
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
Subpotent Drug
Class II
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class III
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class II
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Aero Healthcaredrug
Class II
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II
Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II
Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
CGMP Deviations: Potential presence of metal particulate matter
Class III
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc.drug
Class II
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.
Defective Container
Class II
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
CGMP Deviations: Potential presence of metal particulate matter
Class III
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc.drug
Class II
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lack of Assurance of Sterility: Potential for flexible container leaks.
Class II
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
Product Mix-up
Class II
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II
Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
Presence of Particulate Matter
Class II
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
CGMP Deviations: Potential presence of metal particulate matter
Class II
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class III
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc.drug
Class II
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
CGMP Deviations: Potential presence of metal particulate matter
Class III
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc.drug
Class II
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Failed Tablet/Capsule Specifications
Class II
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Failed Dissolution Specifications
Class II
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class III
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
Tablet/Capsules Imprinted with Wrong ID
Class II
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
Subpotent Drug
Class II
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class III
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Tablet/Capsules Imprinted with Wrong ID
Class II
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Presence of Particulate Matter: Particulate matter identified as glass
Class II
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
Lack of Assurance of Sterility.
Class II
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Failed Dissolution Specifications
Class II
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.
Discoloration
Class III
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Failed Dissolution Specifications
Class II
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30
Lack of Assurance of Sterility:
Class I — Urgent
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Failed Dissolution Specifications
Class II
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Failed Dissolution Specifications
Class III
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.
Failed Impurities/Degradation Specifications
Class III
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc.drug
Class II
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
Failed Content Uniformity Specifications
AvKAREdrug
Class II
Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II
Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II
B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class I — Urgent
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Microbial Contamination of Sterile Products: elevated endotoxin levels
GenoGenix LLCdrug
Class II
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
Lack of assurance of sterility.
Class II
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
GenoGenix LLCdrug
Class II
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp.drug
Class II
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp.drug
Class II
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
Failed Dissolution Specifications.
Class II
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
CGMP Deviations: Market complaints received for gritty texture (grainy)
Class III
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
Cross Contamination with Other Products.
Class III
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
Cross Contamination with Other Products.
Class III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
Failed Impurities/Degradation Specifications:
Class III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
Failed Impurities/Degradation Specifications:
Class III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
Failed Impurities/Degradation Specifications:
Class III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Failed Impurities/Degradation Specifications:
Class III
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Subpotent drug
Class III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
Failed Impurities/Degradation Specifications:
Class II
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Lack of Assurance of Sterility
Class II
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Failed Impurity/Degradation Specifications
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
Superpotent drug
Class II
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class I — Urgent
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Class II
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Failed Impurity/Degradation Specifications
Class II
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
cGMP deviations: Temperature excursion during transportation.
Sandoz Incdrug
Class II
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Presence of a foreign substance.
AvKAREdrug
Class II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Presence of a foreign substance.
AvKAREdrug
Class II
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Subpotent Drug
Class I — Urgent
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I — Urgent
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Presence of Particulate Matter.
Class I — Urgent
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class III
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Subpotent Drug
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class I — Urgent
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class II
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class I — Urgent
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Subpotent Drug
Class I — Urgent
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Presence of Particulate Matter
Class II
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
Subpotent Drug
IMMUNOCORE, LLCdrug
Class II
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Subpotent Drug
Class II
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Discoloration
Class II
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Class II
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class III
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class III
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Cipla USA, Inc.drug
Class II
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Lack of Assurance of Sterility.
PFIZER INCdrug
Class II
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Lack of Assurance of Sterility.
PFIZER INCdrug
Class II
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
Discoloration
Class II
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Failed Dissolution Specifications: low dissolution results
Class II
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Class II
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Merck & Co. Incdrug
Class II
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rxdrug
Class II
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
Presence of foreign substance: identified as aluminum.
Class II
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rxdrug
Class II
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
FDC Limiteddrug
Class II
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
CGMP Deviations; particulates identified during visual inspection
Pfizer Inc.drug
Class II
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class II
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
CGMP Deviations; particulates identified during visual inspection
Pfizer Inc.drug
Class II
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Failed Dissolution Specifications.
Class III
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Cipla USA, Inc.drug
Class II
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Class II
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
Subpotent Drug: Assay below the approved specification
Class II
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15
Subpotent Drug: Assay below the approved specification
Class III
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Qualgen, LLCdrug
Class II
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
CGMP Deviations
Class II
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Class II
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15
Subpotent Drug: Assay below the approved specification
Class II
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17
Subpotent Drug: Assay below the approved specification
Class II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17
Subpotent Drug: Assay below the approved specification
Class II
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
CGMP Deviations
Class II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17
Subpotent Drug: Assay below the approved specification
Class II
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
CGMP Deviations
Class II
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
Subpotent Drug: Assay below the approved specification
Class III
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I — Urgent
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I — Urgent
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Sandoz Incdrug
Class III
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Failed Impurity/Degradation Specifications
AvKAREdrug
Class II
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I — Urgent
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Sandoz Incdrug
Class II
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
Defective container; blister packaging inadequately sealed.
Class II
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I — Urgent
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class II
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class III
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Failed Impurity/Degradation Specifications
AvKAREdrug
Class II
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I — Urgent
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class II
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Defective container; blister packaging inadequately sealed.
Class II
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Presence of foreign tablets/capsules.
Class II
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
Lack of Assurance of Sterility
Apotex Corp.drug
Class II
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Lack of Assurance of Sterility
Class II
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Lack of Assurance of Sterility
Apotex Corp.drug
Class II
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
Discoloration; discolored solution from cracked vials
Pfizer Inc.drug
Class II
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
Lack of Assurance of Sterility
Apotex Corp.drug
Class II
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Class II
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class I — Urgent
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Umary-USA.comdrug
Class II
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Eugia US LLCdrug
Class I — Urgent
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Umary-USA.comdrug
Class II
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Failed Dissolution Specifications
AvKAREdrug
Class I — Urgent
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
SAINI TRADE INCdrug
Class II
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class I — Urgent
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class I — Urgent
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INCdrug
Class II
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
AvKAREdrug
Class II
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class I — Urgent
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INCdrug
Class I — Urgent
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INCdrug
Class I — Urgent
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INCdrug
Class III
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
Presence of a foreign substance: black hair found embedded in tablet.
Class III
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Class II
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
cGMP deviations
Class II
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Class II
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Apotex Corp.drug
Class II
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
OOS results reported for the Dissolution (by UV) test.
Class II
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Failed Impurities/Degradation Specifications
Class I — Urgent
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Class II
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
Defective delivery system
Class II
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
cGMP deviations
KVK Tech, Inc.drug
Class II
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
cGMP deviations
KVK Tech, Inc.drug
Class II
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class II
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
L'Oreal USAdrug
Class II
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit).
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
L'Oreal USAdrug
Class II
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
L'Oreal USAdrug
Class II
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
Lack of Assurance of Sterility
Class II
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
CGMP Deviations
Class II
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
cGMP deviations and lack of assurance of sterility.
Class II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limiteddrug
Class I — Urgent
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Presence of Particulate Matter
Class II
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
Presence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLCdrug
Class II
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
cGMP deviations and lack of assurance of sterility.
Class II
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01
Presence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLCdrug
Class II
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
cGMP deviations and lack of assurance of sterility.
Class II
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01
Presence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLCdrug
Class II
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
cGMP deviations and lack of assurance of sterility.
Class II
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01
Presence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLCdrug
Class II
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.
cGMP deviations and lack of assurance of sterility.
Class II
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01
Presence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLCdrug
Class II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17
Subpotent
Class II
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLCdrug
Class II
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLCdrug
Class II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
Subpotent
Class II
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
cGMP Deviations
Class II
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.
Subpotent
Class II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Subpotent
Class II
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
CGMP Deviations
Medisca Inc.drug
Class II
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class III
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
OurPharma LLCdrug
Class II
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Class II
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Eugia US LLCdrug
Class I — Urgent
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class II
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Chattem Incdrug
Class II
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
CGMP Deviations
Class II
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Class II
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60
CGMP Deviations
Class II
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
CGMP Deviations
Class II
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01
CGMP Deviations
Class II
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97
CGMP Deviations
Class II
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
CGMP Deviations
Class II
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
CGMP Deviations
Class II
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.
CGMP Deviations
Class II
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
CGMP Deviations
Class II
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.
CGMP Deviations
Class III
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Cross Contamination
Class II
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Class II
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
CGMP Deviations
Class II
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
CGMP Deviations
Class II
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60.
CGMP Deviations
Class II
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60
CGMP Deviations
Class II
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.
CGMP Deviations
Class II
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18
CGMP Deviations
Class II
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
CGMP Deviations
Class II
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.
CGMP Deviations
Class II
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
CGMP Deviations
Class II
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60
CGMP Deviations
Class II
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01
CGMP Deviations
Class II
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.
CGMP Deviations
Class II
Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401,
Chemical contamination: Presence of benzene
Alchemee, LLCdrug
Class II
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.
CGMP Deviations
Class II
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08
CGMP Deviations
Class II
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.
CGMP Deviations
Class II
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01
CGMP Deviations
Class II
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
Presence of Particulate Matter
Class II
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60.
CGMP Deviations
Class II
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01
CGMP Deviations
Class II
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01
CGMP Deviations
Class II
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30
CGMP Deviations
Class II
Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60
CGMP Deviations
Class II
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01
CGMP Deviations
Class III
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Cross Contamination
Class II
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01
CGMP Deviations
Class II
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60
CGMP Deviations
Class II
Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,
Chemical contamination: Presence of benzene
Alchemee, LLCdrug
Class II
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60
CGMP Deviations
Class II
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30
CGMP Deviations
Class II
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
CGMP Deviations
Class II
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30
CGMP Deviations
Class II
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01
CGMP Deviations
Class II
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Failed dissolution specifications: lower than specifications
Class III
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class II
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Presence of Foreign Tablets/Capsules.
Class II
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Lack of Assurance of Sterility
Class II
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Lack of Assurance of Sterility
Class I — Urgent
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I — Urgent
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class II
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Lack of Assurance of Sterility
Class I — Urgent
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class II
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
Presence of foreign substance: Presence of Benzene.
Class II
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Class II
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
Lack of Assurance of Sterility
Class II
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Presence of foreign substance: Presence of Benzene.
Class II
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Chemical contamination: presence of benzene
Class II
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Amgen, Inc.drug
Class II
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Failed Dissolution Specifications - low dissolution results
Class II
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limiteddrug
Class II
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
Super-Potent Drug: Out of specification potency results were obtained.
Class II
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
Subpotent Drug
Class II
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
Subpotent Drug
Class II
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Chemical contamination: presence of benzene
Class I — Urgent
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Class II
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Amgen, Inc.drug
Class II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.
Super-Potent Drug: Out of specification potency results were obtained.
Class II
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Failed Dissolution Specifications
Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Chattem Incdrug
Class II
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Chemical Contamination: Presence of benzene.
Class II
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
Chemical Contamination
Class I — Urgent
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class II
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class I — Urgent
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
Presence of Particulate Matter
Class II
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Chemical Contamination: Presence of benzene
Class I — Urgent
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Class II
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.
Chemical Contamination
Class I — Urgent
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class II
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
Failed Dissolution Specifications
Class II
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Failed Impurities/Degradation Specifications
Class II
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Failed Impurities/Degradation Specifications
Class II
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Padagis US LLCdrug
Class II
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.
Class II
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I — Urgent
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Alvogen, Incdrug
Class II
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
AvKAREdrug
Class I — Urgent
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Presence of Particulate Matter.
Provepharm Inc.drug
Class II
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Out of Specification for Dissolution
AvKAREdrug
Class II
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
Failed Dissolution Specifications.
Class II
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class I — Urgent
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
ENDO USA, Inc.drug
Class II
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
Failed Impurities/Degradation Specifications
SKY PACKAGINGdrug
Class II
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
Failed Impurities/Degradation Specifications
SKY PACKAGINGdrug
Class III
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Class II
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Class I — Urgent
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
McKessondrug
Class I — Urgent
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
CGMP Deviations: lack of adequate release testing.
Class II
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class I — Urgent
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
SHOPPERS- PLAZAdrug
Class III
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Appco Pharma LLCdrug
Class II
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
Failed Dissolution Specifications:
Class III
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Presence of Foreign Tablets/Capsules
Class III
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I — Urgent
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Non-Sterility
Class III
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class II
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Incdrug
Class III
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class II
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Incdrug
Class III
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I — Urgent
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc.drug
Class II
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limiteddrug
Class II
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class II
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Eugia US LLCdrug
Class II
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
Failed Stability Specifications
Class II
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I — Urgent
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Buy-Herbaldrug
Class I — Urgent
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc.drug
Class III
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class II
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
CGMP Deviations
Eugia US LLCdrug
Class II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
Presence of Foreign Tablets/Capsules
Class II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I — Urgent
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc.drug
Class I — Urgent
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc.drug
Class II
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class III
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
LABELING: LABEL MIX-UP
AvKAREdrug
Class II
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
Crystallization
Class II
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
Failed Dissolution Specifications
AvKAREdrug
Class II
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class I — Urgent
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
GNMart LLCdrug
Class II
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class III
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Failed Impurities/Degradation Specifications
Class II
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Crystallization
Class III
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
LABELING: LABEL MIX-UP
AvKAREdrug
Class II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Curium US, LLCdrug
Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05
Discoloration
Provepharm Inc.drug
Class II
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
Lack of Sterility Assurance
Class II
Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10
CGMP deviations: out of specifications for assay
Class II
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Failed Impurities/Degradation Specifications
Class II
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
Lack of Sterility Assurance
Class II
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20
Subpotent and Superpotent Drug
Class II
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20
Subpotent and Superpotent Drug
Class II
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20
Subpotent and Superpotent Drug
Class II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20
Subpotent and Superpotent Drug
Class II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-20
Subpotent and Superpotent Drug
Class II
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
CGMP Deviations: Released product should have been rejected.
Class II
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20
Subpotent and Superpotent Drug
Class III
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.
Failed Impurities/Degradation Specifications
Class II
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class III
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Class II
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
Viatris Incdrug
Class II
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Labeling: Label Mix-Up
AvKAREdrug
Class II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
Subpotent drug
Class II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKAREdrug
Class II
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
cGMP Deviations: Out of specification results for micro in hand soap products.
Class I — Urgent
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLCdrug
Class II
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class I — Urgent
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLCdrug
Class III
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Labeling: Not Elsewhere Classified - Wrong NDC number
Class II
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKAREdrug
Class II
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
cGMP Deviations: Out of specification results for micro in hand soap products.
Class I — Urgent
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLCdrug
Class I — Urgent
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLCdrug
Class II
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKAREdrug
Class II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Orthalign, Incdevice
Class II
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Orthalign, Incdevice
Class II
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class I — Urgent
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class I — Urgent
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class II
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class I — Urgent
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
Probes may rupture/burst during activation
Erbe USA Incdevice
Class II
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class III
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class II
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class II
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class I — Urgent
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Class I — Urgent
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Probes may rupture/burst during activation
Erbe USA Incdevice
Class II
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Class I — Urgent
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Class II
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class III
Philips S4-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class II
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
GE Medical Systems, LLCdevice
Class I — Urgent
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class II
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Class II
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
CareFusion 303, Inc.device
Class III
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class III
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class II
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class II
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
Medtronic MiniMed, Inc.device
Class I — Urgent
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Class II
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Class II
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class III
Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class I — Urgent
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Class I — Urgent
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
Class II
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Class II
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Straumann USA LLCdevice
Class II
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Class II
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class II
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class I — Urgent
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Class II
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class III
Philips Mini Multi TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class III
Philips OMNI III TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class II
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Straumann USA LLCdevice
Class II
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class III
Philips 3D6-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class III
Philips X7-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class II
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class II
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class II
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Koven Technology, Inc.device
Class III
Philips C9-4 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class I — Urgent
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Probes may rupture/burst during activation
Erbe USA Incdevice
Class II
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Due to the likely presence of contamination in well(s).
Beckman Coulter, Inc.device
Class II
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class III
Philips L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, Incdevice
Class II
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbHdevice
Class II
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
Medline Industries, LPdevice
Class I — Urgent
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class III
Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
Datascope Corp.device
Class II
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
Class II
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Due to adapter not being properly aligned or locked in place.
Elekta, Inc.device
Class II
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
GE Medical Systems, LLCdevice
Class II
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Diagnostica Stago, Inc.device
Class II
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
ConvaTec, Incdevice
Class II
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
ConvaTec, Incdevice
Class II
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
LeMaitre Vascular, Inc.device
Class II
Cub Pediatric Crib, Model FL19H
Cribs sold in the USA are missing two access door warning labels.
Class II
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
Hologic, Inc.device
Class II
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
GE Medical Systems, LLCdevice
Class II
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Class II
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Class II
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
GE Medical Systems, LLCdevice
Class II
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Drainable large pouch may leak due to manufacturing issue.
ConvaTec, Incdevice
Class II
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class III
Penner Pacific Bathing Spa, Model Numbers 360020-1P
The device does not bear a unique device identifier.
Class II
GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
Class I — Urgent
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Trividia Health, Inc.device
Class II
Artelon FlexBand Dynamic Matrix Ref: 31057
Augmentation devices failed bacterial endotoxin testing.
Class II
GEM Premier 5000; Part No. 00055415005.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class I — Urgent
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Trividia Health, Inc.device
Class II
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Raz Design Incdevice
Class II
GEM Premier 5000; Model No. 00055430010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000; Part No. 00055430008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
GEM Premier 5000; Part No. 00055415008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000 PAK; Part No. 00055407511.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Medline Industries, LPdevice
Class III
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
The device does not bear a unique device identifier.
Class III
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
The device does not bear a unique device identifier.
Class II
GEM Premier 5000 PAK; Part No. 00055360011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
DxC 700 AU, REF: B86444, B86446
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
Class II
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).
Due to pediatric defibrillator electrode delamination
Physio-Control, Inc.device
Class II
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Medartis AGdevice
Class II
GEM Premier 5000 PAK; Part No. 00055407508.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000; Part No. 00055445008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000 PAK; Part No. 00055407510.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000 PAK; Part No. 00055360008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class I — Urgent
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Trividia Health, Inc.device
Class II
GEM Premier 5000; Part No. 00055445004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000; Part No. 00055415010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Augmentation devices failed bacterial endotoxin testing.
Class II
Artelon FlexBand Plus Ref: 41054 & 41057
Augmentation devices failed bacterial endotoxin testing.
Class II
GEM Premier 5000; Part No. 00055430004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class III
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
Class II
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Covidien LLCdevice
Class III
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
The device does not bear a unique device identifier.
Class III
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
The device does not bear a unique device identifier.
Class II
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class III
Penner Pacific Bathing Spa, Model Numbers 860010-1L
The device does not bear a unique device identifier.
Class II
GEM Premier 5000; Part No: 00055415011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class III
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
The device does not bear a unique device identifier.
Class II
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Product not cleared by the FDA.
Altruan GmbHdevice
Class II
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Class I — Urgent
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Trividia Health, Inc.device
Class III
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
The device does not bear a unique device identifier.
Class II
IBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
Class II
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
GEM Premier 5000; Part No. 00055430011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
Medline Industries, LPdevice
Class II
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
Medline Industries, LPdevice
Class II
CLARITY II Laser System; Model No. 1110200210.
Reports of devices sparking/popping and potentially burning patients.
Lutronic Corporationdevice
Class II
GEM Premier 5000 PAK; Part No. 00055360010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000 PAK; Part No. 00055415004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Medartis AGdevice
Class II
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Product not cleared by the FDA.
Altruan GmbHdevice
Class III
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.
Class II
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Product not cleared by the FDA.
Altruan GmbHdevice
Class II
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Class II
GEM Premier 5000 PAK; Part No. 00055407504.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Class II
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class II
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Potential for rubber fragment detachment during use.
Class I — Urgent
Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.device
Class II
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Potential for rubber fragment detachment during use.
Class I — Urgent
Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.device
Class II
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Class II
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
B Braun Medical Incdevice
Class I — Urgent
Impella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.device
Class II
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
There is the potential for the length of the trocar shaft to be too long.
Aesculap Incdevice
Class II
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
ESAOTE S.P.A.device
Class II
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
Class II
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
GE Healthcaredevice
Class II
CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Datascope Corp.device
Class II
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Class II
CS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Datascope Corp.device
Class II
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
B Braun Medical Incdevice
Class II
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
B Braun Medical Incdevice
Class II
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Class II
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Diagnostica Stago, Inc.device
Class II
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Vascutek, Ltd.device
Class II
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Class II
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Industries, LPdevice
Class II
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Industries, LPdevice
Class II
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Knee and Humeral socket implants contain incorrect labeling.
Encore Medical, LPdevice
Class II
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
MRIMed Inc.device
Class II
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Industries, LPdevice
Class II
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Class II
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline Industries, LPdevice
Class II
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Industries, LPdevice
Class II
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Industries, LPdevice
Class II
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Knee and Humeral socket implants contain incorrect labeling.
Encore Medical, LPdevice
Class II
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Software anomaly in the patient positioning system may result in positional discrepancy.
Class II
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline Industries, LPdevice
Class II
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lack of 510K clearance
Edermy LLCdevice
Class II
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Remel, Incdevice
Class II
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Class II
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Knee and Humeral socket implants contain incorrect labeling.
Encore Medical, LPdevice
Class II
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline Industries, LPdevice
Class II
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline Industries, LPdevice
Class II
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Software anomaly in the patient positioning system may result in positional discrepancy.
Class II
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
PIE Trolley System Model: 2005
Lack of 510K clearance
Edermy LLCdevice
Class II
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline Industries, LPdevice
Class II
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
Agiliti Health - Ellisdevice
Class II
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Estrone RIA, REF: DSL8700
The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Immunotech A.S.device
Class II
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Due to damage to outer tray that can potentially compromise the sterile barrier
Class II
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Class II
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 6) PICC CATHETER INSERTION TRAY, Model Number: CVI4300
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Medline Industries, LPdevice
Class II
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Auris Health, Incdevice
Class II
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 7) ROBOTIC PACK, Model Number: DYNJ04135B; 8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 10) D&C PACK-LF, Model Number: DYNJ22567G; 11) D&C PACK-LF, Model Number: DYNJ22567J; 12) D AND C, Model Number: DYNJ41272B; 13) D AND C, Model Number: DYNJ41272C; 14) OB PACK, Model Number: DYNJ42884; 15) D&C/GYN PACK, Model Number: DYNJ47713A; 16) PERI GYN PACK, Model Number: DYNJ55377D; 17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 18) D&C PACK, Model Number: DYNJ67214D; 19) D&C PACK, Model Number: DYNJ67214F; 20) D&C PACK, Model Number: DYNJ67214G; 21) D&C PACK, Model Number: DYNJ67214I; 22) LITHOTOMY PACK, Model Number: DYNJ80765C; 23) GYN PACK, Model Number: DYNJ83475; 24) D AND C PACK, Model Number: DYNJ87468; 25) D&C-ASC, Model Number: DYNJ900465C; 26) D&C-ASC, Model Number: DYNJ900465D; 27) D&C-ASC, Model Number: DYNJ900465F; 28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 30) D&C, Model Number: DYNJ906947C; 31) PACK PERI GYN DSMC, Model Number: DYNJT6424
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Class I — Urgent
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
Class II
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK, Model Number: DYNJ87378A; 60) ENT PACK, Model Number: DYNJ87378D; 61) ENT SPLIT PACK, Model Number: DYNJ87451; 62) ENT SINUS PACK, Model Number: DYNJ88498; 63) NASAL, Model Number: DYNJ902993F; 64) ENDO SINUS-MIDTOWN, Model Number: DYNJ905866; 65) T A, Model Number: DYNJ906292B; 66) THYROID, Model Number: DYNJ906841A; 67) THYROID - SMH AMB, Model Number: DYNJ907739B; 68) ENT, Model Number: DYNJ911623; 69) HEAD AND NECK PACK, Model Number: DYNJT5739; 70) RO MEDIASTINAL PACK-LF, Model Number: PHS393087007C
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class I — Urgent
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
Class II
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A; 9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B; 10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183; 11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A; 12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B; 13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A; 14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39; 15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A; 16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C; 17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46; 18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54; 19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69; 20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A; 21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B; 22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78; 23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A; 24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B; 25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84; 26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C; 27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G; 28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J; 29) BREAST PACK ASC-LF, Model Number: DYNJ36469I; 30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J; 31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F; 32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K; 33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M; 34) BREAST PACK, Model Number: DYNJ50957G; 35) PLASTICS BREAST PACK, Model Number: DYNJ55358G; 36) BHN IMPLANT PACK, Model Number: DYNJ56737A; 37) BREAST PACK, Model Number: DYNJ60210A; 38) PLASTICS PACK 2, Model Number: DYNJ64927F; 39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A; 40) BREAST IMPLANT PACK, Model Number: DYNJ69351; 41) BREAST/TUMMY PACK, Model Number: DYNJ83788; 42) HMSL PLASTICS, Model Number: DYNJ83884B; 43) CHEST/BREAST-LF, Model Number: DYNJ83950A; 44) CHEST/BREAST-LF, Model Number: DYNJ83950B; 45) FREE FLAP A DIRTY, Model Number: DYNJ86165; 46) MAJOR SURGERY PACK, Model Number: DYNJ86816; 47) BREAST REDUCTION PACK, Model Number: DYNJ87444; 48) OMF FREE FLAP, Model Number: DYNJ902005I; 49) BREAST CDS, Model Number: DYNJ902558G; 50) TRUNCAL CONTOURING, Model Number: DYNJ903555D; 51) TRUNCAL CONTOURING, Model Number: DYNJ903555F; 52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C; 53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A; 54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A; 55) FACELIFT, Model Number: DYNJ910462; 56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283; 57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417; 58) PLASTICS PACK-LF, Model Number: PHS806973G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 15) NEURO PACK, Model Number: DYNJ49098I; 16) NEURO PACK, Model Number: DYNJ53089B; 17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 20) NEURO PACK, Model Number: DYNJ60792B; 21) NEURO PACK, Model Number: DYNJ60792C; 22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 25) NEURO PACK, Model Number: DYNJ61740D; 26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 28) DISCECTOMY PACK, Model Number: DYNJ67835; 29) WWD NEURO PACK, Model Number: DYNJ80849B; 30) WWD NEURO PACK, Model Number: DYNJ80849J; 31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 32) NEURO, Model Number: DYNJ900904J; 33) NEURO, Model Number: DYNJ900904K; 34) NEURO, Model Number: DYNJ900904L; 35) NEURO, Model Number: DYNJ900904M; 36) NEURO, Model Number: DYNJ902585; 37) NEURO, Model Number: DYNJ902585A; 38) NEURO - IFCAP 230316, Model Number: DYNJ908393; 39) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 40) NEURO KIT, Model Number: DYNJ909573; 41) NEURO, Model Number: DYNJ910384; 42) NEURO, Model Number: DYNJ910384A; 43) NEURO PACK-LF, Model Number: PHS390015M
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOWN,SIRUS,NONRNF,XLN/XL,20/CS, Model Number: DYNJP2002SL; 6) GOWN,NONRNF,2XL,18/CS, Model Number: DYNJP2003; 7) GOWN,SIRUS,NONRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2003S; 8) GOWN,SIRUS,NONRNF,XLN/2XL,18/CS, Model Number: DYNJP2003SL; 9) GOWN,NONRNF,3XL,18/CS, Model Number: DYNJP2004; 10) GOWN,SIRUS,NONRNF,3XL,18/CS, Model Number: DYNJP2004S; 11) GOWN,NONRNF,SM,30/CS, Model Number: DYNJP2005; 12) GOWN,SIRUS,NONRNF,SM,30/CS, Model Number: DYNJP2005S; 13) GOWN,NONRNF,4XL,18/CS, Model Number: DYNJP2009; 14) GOWN,SIRUS,NONRNF,4XL,18/CS, Model Number: DYNJP2009S; 15) GOWN,ECLIPSE,FABRNF,L,30/CS, Model Number: DYNJP2101; 16) GOWN,SIRUS,FABRNF,L,20/CS, Model Number: DYNJP2101S; 17) GOWN,ECLIPSE,FABRNF,XL,30/CS, Model Number: DYNJP2102; 18) GOWN,SIRUS,FABRNF,XL,20/CS, Model Number: DYNJP2102S; 19) GOWN,ECLIPSE,FABRNF,2XL,18/CS, Model Number: DYNJP2103; 20) GOWN,SIRUS,FABRNF,2XL,18/CS, Model Number: DYNJP2103S; 21) GOWN,ECLIPSE,POLYRNF,L,30/CS, Model Number: DYNJP2201; 22) GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS, Model Number: DYNJP2201S; 23) GOWN,ECLIPSE,POLYRNF,XL,30/CS, Model Number: DYNJP2202; 24) GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2202S; 25) GOWN,ECLIPSE,POLYRNF,2XL,18/CS, Model Number: DYNJP2203; 26) GOWN,SIRUS,POLYRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2203S; 27) GOWN,ECLIPSE,POLYRNF,XLN/L,28/CS, Model Number: DYNJP2204; 28) GOWN,SIRUS,POLYRNF,XLN/LG,20/CS, Model Number: DYNJP2204S; 29) GOWN,ECLIPSE,POLYRNF,XLN/XL,28/CS, Model Number: DYNJP2205; 30) GOWN,SIRUS,POLYRNF,XLN/XL,20/CS, Model Number: DYNJP2205S; 31) GOWN,ECLIPSE,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206; 32) GOWN,SIRUS,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206S; 33) DBQ-GOWN,PREVENTION PLUS,LN/L,ST,24/CS, Model Number: DYNJP2301P; 34) DBQ-GOWN,PREVENTION PLUS,XLN/XL,ST,24/CS, Model Number: DYNJP2302P; 35) DBD-GOWN,PREVENTION PLUS,XLN/2XL,ST,22/C, Model Number: DYNJP2303P; 36) DBD-GOWN,PREVENTION PLUS,L,ST,24/CS, Model Number: DYNJP2306P; 37) DBQ-GOWN,PREVENTION PLUS,XL,ST,24/CS, Model Number: DYNJP2307P; 38) DBQ-GOWN,PREVENTION PLUS,2XL,ST,22/CS, Model Number: DYNJP2308P; 39) GOWN,ORBIS,LVL 3,LRG/XLONG,ST,24/CS, Model Number: DYNJP2361P; 40) GOWN,ORBIS,LVL 3,XLONG/XLARGE,ST,24/CS, Model Number: DYNJP2362P; 41) GOWN,ORBIS,LVL 3,XLNG/XXLARGE,ST,22/CS, Model Number: DYNJP2363P; 42) GOWN,ORBIS,LVL 3,LARGE,ST,24/CS, Model Number: DYNJP2366P; 43) GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS, Model Number: DYNJP2367P; 44) GOWN,ORBIS,LVL 3,XXLARGE,ST,22/CS, Model Number: DYNJP2368P; 45) GOWN,ORBIS,LVL 3,4XL,ST,20/CS, Model Number: DYNJP2369P; 46) GOWN,SIRUS,NONRNF,RAGLAN,L,ST,32/CS, Model Number: DYNJP2401; 47) GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS, Model Number: DYNJP2402; 48) GOWN,SIRUS,NONRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2403; 49) GOWN,SIRUS,FABRNF,RAGLAN,L,ST,30/CS, Model Number: DYNJP2501; 50) GOWN,SIRUS,FABRNF,RAGLAN,XL,ST,28/CS, Model Number: DYNJP2502; 51) GOWN,SIRUS,FABRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2503; 52
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Stryker Corporationdevice
Class II
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 10) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 11) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 12) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 16) CVC PACK, Model Number: CVI4500A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
Potential packaging failures, which could lead to a breach in the sterile barrier.
Class II
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) MINOR EYE PACK, Model Number: DYNJ17219C; 12) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 13) EYE PACK, Model Number: DYNJ41207C; 14) OPHTHALMIC PACK, Model Number: DYNJ42043I; 15) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 16) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 17) EYE PLASTIC PACK, Model Number: DYNJ47859B; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) CATARACT PACK, Model Number: DYNJ53019A; 20) CATARACT PACK, Model Number: DYNJ54869A; 21) VITRECTOMY PACK, Model Number: DYNJ55280B; 22) NDNW-EYE PACK, Model Number: DYNJ61779C; 23) EYE PK, Model Number: DYNJ62306; 24) VITRECTOMY, Model Number: DYNJ64220; 25) OSC BREAST PACK, Model Number: DYNJ65808C; 26) MILLS CATARACT PACK, Model Number: DYNJ67973A; 27) EYE PACK, Model Number: DYNJ68367B; 28) CATARACT PACK, Model Number: DYNJ68875D; 29) CATARACT PACK, Model Number: DYNJ68875F; 30) CATARACT PACK, Model Number: DYNJ68875G; 31) OPHTHO PLASTIC, Model Number: DYNJ902256C; 32) RETINAL, Model Number: DYNJ907495; 33) CATARACT, Model Number: DYNJ909924; 34) COMBO EYE, Model Number: DYNJ909925; 35) VITRECTOMY, Model Number: DYNJ909929
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class I — Urgent
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
Class II
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I; 12) CATH LAB PACK, Model Number: DYNJ31773K; 13) CATH PACK-LF, Model Number: DYNJ33061D; 14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D; 15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M; 16) CATH LAB PK, Model Number: DYNJ35643C; 17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B; 18) CATH PACK-LF, Model Number: DYNJ43101C; 19) OR ANGIO PACK-LF, Model Number: DYNJ43415D; 20) OR ANGIO PACK-LF, Model Number: DYNJ43415F; 21) ANGIOPLASTY PACK, Model Number: DYNJ44700J; 22) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 23) RADIOLOGICAL PACK, Model Number: DYNJ44889O; 24) CARDIAC CATH PACK, Model Number: DYNJ47370B; 25) ANGIOGRAPHY PACK, Model Number: DYNJ53129D; 26) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ56772G; 27) DR. MOHINDRA PACK, Model Number: DYNJ57602G; 28) NE ENDO VASCULAR PACK, Model Number: DYNJ57940B; 29) CARDIAC CATH PACK - Q1, Model Number: DYNJ58048C; 30) OR ANGIO, Model Number: DYNJ59931B; 31) LPCH PERRY CATH PACK, Model Number: DYNJ67378C; 32) HOSPITAL REGIONAL DE CONCEPCIO, Model Number: DYNJ67918A; 33) CATH LAB PACK, Model Number: DYNJ68633; 34) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197B; 35) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197C; 36) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197D; 37) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197F; 38) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197G; 39) BASIC CARDIAC CATH PACK, Model Number: DYNJ81593B; 40) UMC EL PASO CATH PACK, Model Number: DYNJ83089; 41) DR. MOHINDRA PACK, Model Number: DYNJ83819A; 42) VZ VAS/ANG PACK, Model Number: DYNJ83981; 43) WCPN CARDIOLOGY PACK, Model Number: DYNJ84539; 44) CATH LAB, Model Number: DYNJ85511; 45) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJT1520K; 46) ANGIOGRAPHY TRAY, Model Number: MNS9130; 47) CVC BUNDLE KIT, Model Number: ECVC6225A; 48) CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Products were mislabeled as the 6mm product but included the 5 mm product.
Centinel Spine, Inc.device
Class II
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Class II
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Industries, LPdevice
Class II
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Elekta, Inc.device
Class III
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDdevice
Class II
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class III
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDdevice
Class II
Brilliance iCT; Product Code (REF): 728306;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Class II
Spectral CT; Product Code (REF): 728333;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Class I — Urgent
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class II
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Medline Industries, LPdevice
Class II
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class I — Urgent
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class I — Urgent
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
Class II
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Intuitive Surgical, Inc.device
Class II
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class II
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Tyvek bag seal issue which may compromise sterility of the kit.
AVID Medical, Inc.device
Class II
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class II
IQon Spectral CT; Product Code (REF): 728332;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Class II
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Due a design issue where the navigated array connection geometry is incorrect.
Alphatec Spine, Inc.device
Class III
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Straumann USA LLCdevice
Class I — Urgent
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class II
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class III
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDdevice
Class II
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class II
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Steris Corporationdevice
Class II
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Elekta, Inc.device
Class II
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class III
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDdevice
Class II
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Medline Industries, LPdevice
Class III
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL LTDdevice
Class II
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Due a design issue where the navigated array connection geometry is incorrect.
Alphatec Spine, Inc.device
Class II
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Hologic, Incdevice
Class I — Urgent
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class I — Urgent
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class I — Urgent
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline Industries, LPdevice
Class II
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline Industries, LPdevice
Class II
Spectral CT 7500 on Rails; Product Code (REF): 728334;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Class II
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Beckman Coulter, Inc.device
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse pTau 217 Plasma Controls: Liquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
ETAC A/Sdevice
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Male Fertility Sperm Test for Home Use (Cassette)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Biomerieux Incdevice
Class II
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
ETAC A/Sdevice
Class II
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class I — Urgent
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class I — Urgent
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Focalyx Fusion
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Class II
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Vivoo Protein Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class I — Urgent
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
XXX
Vortex Surgical Inc.device
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Vortex Surgical I2 Injection Kit, VS0500
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class I — Urgent
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Class II
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse ¿-Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454 Component: No
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse ¿-Amyloid Plasma Controls: Liquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Medtronic MiniMed, Inc.device
Class II
S. Typhi/Para Typhi A Antigen
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-¿-amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-¿-amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Tornier, Incdevice
Class II
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
Tecfen Retractable Membrane Polisher, QTPR1267-23
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Vivoo pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
25GA Subretinal Injection Cannula VS0220.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II
CellMek SPS Sample Preparation System, REF: C44603, with software
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
Beckman Coulter, Inc.device
Class II
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 ¿ 1.5 mL (4 Concentrations) CAL 1 0 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class I — Urgent
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class I — Urgent
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II
LH One Step Ovulation Test Device (Urine)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
Class II
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
ETAC A/Sdevice
Class II
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Class II
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
ETAC A/Sdevice
Class II
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Class II
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
Intuitive Surgical, Inc.device
Class II
Menopause Test Cassette (Urine)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.device
Class II
Vivoo Vaginal pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Class II
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
LSL Healthcare Inc.device
Class II
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F; 11) NORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L; 12) KNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B; 13) KNEE ARTHROSCOPY PACK-LF, Kit SKU DYNJ66150; 14) HIP PACK, Kit SKU DYNJ66630; 15) OHNS FREE FLAP A PACK, Kit SKU DYNJ69065F; 16) LUMBAR PACK, Kit SKU DYNJ69113C; 17) LAMINECTOMY PACK, Kit SKU DYNJ69401D; 18) LAMINECTOMY PACK, Kit SKU DYNJ81013D; 19) HIP/SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ84275A; 20) FLASC ACL PACK, Kit SKU DYNJ88971; 21) SPINE PACK MERCY GALENA, Kit SKU DYNJ89943; 22) SPINAL FUSION MT CARMEL, Kit SKU DYNJ900173J; 23) HAND, Kit SKU DYNJ904945G; 24) LAMINECTOMY, Kit SKU DYNJ909505D; 25) SHOULDER SPLIT, Kit SKU DYNJ910543F; 26) SHOULDER SPLIT, Kit SKU DYNJ910543G; 27) CRANIOTOMY PACK, Kit SKU DYNJT4724; 28) SPINE PACK, Kit SKU DYNJT5184.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
AlternatiV+ Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Genesis Push-In Suture Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class I — Urgent
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCdevice
Class II
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 13) PEDIATRIC MOSES, Kit SKU DYNJ58864B; 14) LAPAROTOMY PACK, Kit SKU DYNJ59313B; 15) CRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F; 16) LAP GASTRIC PACK, Kit SKU DYNJ62065A; 17) MINOR PACK, Kit SKU DYNJ64174A; 18) GENERAL SURGERY PACK, Kit SKU DYNJ64258I; 19) GENERAL LAP SHARED-LF, Kit SKU DYNJ64786D; 20) CHOLE PACK, Kit SKU DYNJ67686B; 21) GEN SURG MINOR PACK, Kit SKU DYNJ69142F; 22) LAP CHOLE PACK, Kit SKU DYNJ81695B; 23) GENERAL LAPAROSCOPY, Kit SKU DYNJ900901K; 24) GEN MINOR, Kit SKU DYNJ900906L; 25) ROBOTIC GENERAL, Kit SKU DYNJ906861D; 26) RMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C; 27) LAP CHOLE LMC CDS, Kit SKU DYNJ911116A; 28) MINOR GENERAL PACK, Kit SKU DYNJT3884; 29) GENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504; 30) MINOR SURGERY PACK-LF, Kit SKU PHS109062D.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
BEAR Implant. Model Number: 1000.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Miach Orthopaedicsdevice
Class II
Fixone Biocomposite Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Fixone Hybrid Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K; 6) CENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S; 7) SPINE PACK-LF, Kit SKU DYNJ0376635Q; 8) ORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T; 9) W.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J; 10) NEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W; 11) ANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T; 12) MINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ0753436P; 13) KNEE SCOPE PACK-LF, Kit SKU DYNJ0890502R; 14) PEDIATRIC PACK-LF, Kit SKU DYNJ28212L; 15) ANTERIOR CERVICAL PACK, Kit SKU DYNJ31341P; 16) PEDIATRIC MINOR PROCEDURE PACK, Kit SKU DYNJ37615J; 17) LAPAROSCOPY PACK, Kit SKU DYNJ39215N; 18) MAJOR LAP VCH, Kit SKU DYNJ39217P; 19) NEURO PACK, Kit SKU DYNJ39220N; 20) CAS HAND PK, Kit SKU DYNJ39468G; 21) RFT ISC NOBLES MINOR PACK, Kit SKU DYNJ43954B; 22) PED OPEN HEART PACK, Kit SKU DYNJ45373G; 23) MAJOR GENERAL PACK-LF, Kit SKU DYNJ51436F; 24) MINOR PK-LF, Kit SKU DYNJ51437C; 25) VEIN ABLATION & EXCISION ASC, Kit SKU DYNJ52586C; 26) SHOULDER PACK, Kit SKU DYNJ56889B; 27) LAP CHOLE PACK, Kit SKU DYNJ57206F; 28) TRANSGENDER MASTECTOMY 2, Kit SKU DYNJ58257I; 29) SHOULDER ARTH PACK, Kit SKU DYNJ58410D; 30) MAJOR PACK, Kit SKU DYNJ58528J; 31) PACK BREAST, Kit SKU DYNJ60157F; 32) CH TRANSPHENOIDAL PACK, Kit SKU DYNJ61696I; 33) RR-SPINE PACK, Kit SKU DYNJ62643B; 34) MINOR PACK, Kit SKU DYNJ64238D; 35) PBMS NECK PACK-LF, Kit SKU DYNJ64961C; 36) BREAST PACK, Kit SKU DYNJ64988C; 37) MINOR PACK 180110, Kit SKU DYNJ65447C; 38) PACK,V-P SHUNT, Kit SKU DYNJ65472C; 39) BASIC PACK, Kit SKU DYNJ65996D; 40) MINOR SS, Kit SKU DYNJ66094A; 41) CRMC ROBOTIC GENERAL PACK, Kit SKU DYNJ66613D; 42) PEDIATRIC GENERAL PACK, Kit SKU DYNJ66644F; 43) URO/GYN PACK, Kit SKU DYNJ66675F; 44) SHOULDER SCOPE PACK, Kit SKU DYNJ68707B; 45) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844B; 46) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844C; 47) ACF PACK, Kit SKU DYNJ69112C; 48) SM OR-DR. YEH PACK-LF, Kit SKU DYNJ69705C; 49) SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ81752C; 50) C BIRTH SET UP PACK, Kit SKU DYNJ81994C; 51) TRIAL PACK, Kit SKU DYNJ82770A; 52) PROSTATE ROBOTIC PACK, Kit SKU DYNJ84120C; 53) HAND PACK, Kit SKU DYNJ85033A; 54) ARTHROSCOPY PACK, Kit SKU DYNJ85197A; 55) GU-GYN-LITHO PACK, Kit SKU DYNJ86013A; 56) DBD-ARTHROSCOPY PACK, Kit SKU DYNJ86963A; 57) BREAST PACK, Kit SKU DYNJ87587A; 58) PACK,PEDIATRIC MINOR, Kit SKU DYNJ88718; 59) UNIVERSAL-ASC, Kit SKU DYNJ900071C; 60) BASIC, Kit SKU DYNJ905869G; 61) PACK,PEDIATRIC MAJOR, Kit SKU DYNJ906888F; 62) HAND/FOOT PACK, Kit SKU DYNJT3131A; 63) SHOULDER PACK, Kit SKU DYNJT3266; 64) LUMBAR PACK, Kit SKU DYNJT4178; 65) CVS ICU PACK, Kit SKU PHS41728D; 66) SINGLE TAP BLOCK TRAY, Kit SKU SPEC0156A.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Cardinal Health 200, LLCdevice
Class II
Genesis Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT.
Potential exposure of rodents and rodent activity in the distribution center.
Class II
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Incorrect expiration date
Cerapedics, Inc.device
Class II
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
Potential exposure of rodents and rodent activity in the distribution center.
Class II
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO SHUNT BUMC, Kit SKU DYNJT6428.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class II
AlternatiV+ Max Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class I — Urgent
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCdevice
Class II
Genesis Dual Thread Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .
Potential exposure of rodents and rodent activity in the distribution center.
Class II
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Incorrect expiration date
LimFlow, Inc.device
Class I — Urgent
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCdevice
Class II
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II
PREGNANCY TEST 24CT
Potential exposure of rodents and rodent activity in the distribution center.
Class II
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II
Genesis Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Aju Pharm Co., Ltd.device
Class II
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Philips North Americadevice
Class I — Urgent
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCdevice
Class II
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
Potential exposure of rodents and rodent activity in the distribution center.
Class II
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
Class II
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline Industries, LPdevice
Class II
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
CareFusion 303, Inc.device
Class II
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Allwell Inflation Device, for angiographic use REF: IS-30-A
Inflation device handle may detach from the syringe during procedure.
Class II
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A
Inflation device handle may detach from the syringe during procedure.
Class II
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
ICU Medical, Inc.device
Class II
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
ICU Medical, Inc.device
Class II
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
ICU Medical, Inc.device
Class II
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
Class II
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
Potential for fraying on the body support strap.
Community Products, LLCdevice
Class II
Merit Medical , Custom Manifold Kit REF: K09-13203A
Inflation device handle may detach from the syringe during procedure.
Class II
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Inflation device handle may detach from the syringe during procedure.
Class II
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Tyber Medicaldevice
Class II
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.
Potential for fraying on the body support strap.
Community Products, LLCdevice
Class II
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO
The console label for affected devices is missing the "DANGER" symbol.
LEASEIR TECHNOLOGIES SLUdevice
Class II
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Class II
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
Inflation device handle may detach from the syringe during procedure.
Class II
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
ICU Medical, Inc.device
Class II
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Inflation device handle may detach from the syringe during procedure.
Class II
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Due to products not having FDA Premarket authorization to be distributed within the United States.
Class II
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Sysmex America, Inc.device
Class II
Allwell Angioplasty Pack REF: IS-30-B1/B
Inflation device handle may detach from the syringe during procedure.
Class II
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Patient Information Center iX; Software Version Number: 4.5.0
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Philips North Americadevice
Class II
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Tyber Medicaldevice
Class II
Mazor X robotic guidance system REF: TPL0059
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Mazor Robotics Ltddevice
Class II
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
Class II
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Intuitive Surgical, Inc.device
Class II
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.
Potential for fraying on the body support strap.
Community Products, LLCdevice
Class II
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan Diagnosticsdevice
Class II
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Elekta, Inc.device
Class II
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Class II
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Medline Industries, LPdevice
Class II
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Intuitive Surgical, Inc.device
Class II
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Labeling error, Incorrect expiration date
Class II
Allura Xper FD10F; Model Number: 722002;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Class II
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Medicrea Internationaldevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Allura Xper FD10/10; Model Number: 722027;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Allura Xper FD20; Model Number: 722028;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Product Name: Allura Xper FD10C; Model number: 722001;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Class II
Allura Xper FD10; Model Number: 722003;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Medline Industries, LPdevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Mobius Imaging, LLCdevice
Class II
Allura Xper FD10/10; Model Number: 722011;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Allura Xper FD20/20; Model Number: 722038;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Allura Xper FD10/10; Model Number: 722005;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Allura Xper FD20; Model Number: 722012;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
ICU Medical Inc.device
Class II
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Medline Industries, LPdevice
Class II
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Diagnostica Stago, Inc.device
Class II
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Fungal contamination of affected lot with Parengyodontium album.
Hologic, Incdevice
Class II
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Class II
Allura Xper FD20/10; Model Number: 722029;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
Class II
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
Fresenius Kabi USA, LLCdevice
Class II
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Mobius Imaging, LLCdevice
Class II
Allura Xper FD10; Model Number: 722010;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Portex Spinal Tray, Item No. A3729-24 A3595
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
ICU Medical Inc.device
Class II
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Medicrea Internationaldevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Allura Xper FD20 Biplane; Model Number: 722008;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Potential for microbial contamination.
Class II
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
Thoratec LLCdevice
Class II
Plum Duo Infusion System, List Number 40002-04-01
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
ICU Medical, Inc.device
Class II
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Medtronic Incdevice
Class II
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
Class II
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Medline Industries, LPdevice
Class II
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Medline Industries, LPdevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Allura Xper FD20 OR Table; Model Number: 722023;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Allura Xper FD20 Biplane; Model Number: 722013;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.
C-RAD POSITIONING ABdevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline Industries, LPdevice
Class II
Allura Xper FD10; Model Number: 722026;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Allura Xper FD20; Model Number: 722006;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Medline Industries, LPdevice
Class II
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
CareFusion 303, Inc.device
Class II
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
Sophysadevice
Class II
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Medline Industries, LPdevice
Class II
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Beckman Coulter, Inc.device
Class II
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Beckman Coulter, Inc.device
Class I — Urgent
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Devices are not suitable for organ transplant.
AVID Medical, Inc.device
Class I — Urgent
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Devices are not suitable for organ transplant.
AVID Medical, Inc.device
Class II
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
IMRIS Imaging Incdevice
Class II
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
The affected lots show a decline in performance over time, which may lead to false-negative results.
Meridian Bioscience Incdevice
Class II
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
Class I — Urgent
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Devices are not suitable for organ transplant.
AVID Medical, Inc.device
Class II
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Class II
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Class II
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Securitas Healthcare LLCdevice
Class II
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Securitas Healthcare LLCdevice
Class II
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
Class II
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Philips Ultrasound, LLCdevice
Class II
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
Butyrate tube cracks during actuation, rendering product unusable.
Class II
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Class II
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
CareFusion 303, Inc.device
Class II
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
ICU Medical, Inc.device
Class II
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class I — Urgent
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc.device
Class II
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Microbiologics Incdevice
Class II
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol, Incdevice
Class II
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol, Incdevice
Class II
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol, Incdevice
Class II
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
Intuitive Surgical, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
ICU Medical, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
AGFA Healthcare Corp.device
Class II
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Microbiologics Incdevice
Class II
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Microbiologics Incdevice
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol, Incdevice
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Class II
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol, Incdevice
Class I — Urgent
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Alcon Research LLCdevice
Class I — Urgent
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Zimmer, Inc.device
Class II
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol, Incdevice
Class II
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Cepheiddevice
Class II
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Removal of affected lot of screws due to labeling error.
Smith & Nephew, Inc.device
Class II
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Class II
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Class II
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Abbott Laboratoriesdevice
Class III
Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope Corp.device
Class I — Urgent
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Class II
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105 502-106 - Calf Implant style 1 size 6 UDI-DI code: B490502106 502-201 - Calf Implant style 2 size 1 UDI-DI code: B490502201 502-303 - Calf Implant style 3 size 3 UDI-DI code: B490502303 502-304 - Calf Implant style 3 size 4 UDI-DI code: B490502304
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
DSAART LLCdevice
Class II
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
DSAART LLCdevice
Class III
Cardiosave Hybrid
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope Corp.device
Class I — Urgent
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Fresenius Kabi USA, LLCdevice
Class II
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
DSAART LLCdevice
Class I — Urgent
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Class II
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Cepheiddevice
Class II
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
DSAART LLCdevice
Class II
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
Class II
InPen App, Model/CFN Number: MMT-8061 (Android Users)
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
Medtronic MiniMed, Inc.device
Class II
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Medline Industries, LPdevice
Class II
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Medline Industries, LPdevice
Class II
Intelerad InteleShare software, with ProViewer component
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
DICOM Grid, Inc.device
Class II
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
DSAART LLCdevice
Class II
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
DSAART LLCdevice
Class I — Urgent
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Class II
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Datascope Corp.device
Class II
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Steris Corporationdevice
Class II
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Steris Corporationdevice
Class II
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
C.R. Bard Incdevice
Class III
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCdevice
Class II
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
C.R. Bard Incdevice
Class II
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Beckman Coulter, Inc.device
Class II
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Cardinal Health 200, LLCdevice
Class II
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Datascope Corp.device
Class II
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
C.R. Bard Incdevice
Class III
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCdevice
Class III
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5¿ Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5¿ Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5¿ Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5¿ Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5¿ Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5¿ Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5¿ Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5¿ Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5¿ Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5¿ Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5¿ Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10¿ Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10¿ Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10¿ Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10¿ Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10¿ Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10¿ Lordotic;
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCdevice
Class II
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Class II
Stryker Arise 1000EX mattress, Part Number 2236000000
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
Class II
Stryker MV3 bariatric bed, Part Number 5900000001
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
Class II
DEXLOCK Achilles Repair Implant Kits, MAKT4520
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
Medline Industries, LPdevice
Class II
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
Medline Industries, LPdevice
Class II
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Screw may loosen or fallout of Hemodialysis system
Class III
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCdevice
Class III
Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT;
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCdevice
Class III
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCdevice
Class II
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
C.R. Bard Incdevice
Class II
IntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Food Intolerance Test Small
Distribution without premarket approval/clearance.
Class II
IntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Vitamin D-Test
Distribution without premarket approval/clearance.
Class II
Candida Test
Distribution without premarket approval/clearance.
Class II
Organic Acids Profile Test Large
Distribution without premarket approval/clearance.
Class II
Allergy Test IgE
Distribution without premarket approval/clearance.
Class II
Allergy test Small
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
Class II
GI Microbiome Profile XL
Distribution without premarket approval/clearance.
Class II
Illegally Marketed
Distribution without premarket approval/clearance.
Class II
HPV Antigen Test
Distribution without premarket approval/clearance.
Class II
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Philips Ultrasound, LLCdevice
Class II
Sperm Test
Distribution without premarket approval/clearance.
Class II
Mycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
Class II
Parasite Test
Distribution without premarket approval/clearance.
Class II
Adrenal Test
Distribution without premarket approval/clearance.
Class II
Neurotransmitters Plus
Distribution without premarket approval/clearance.
Class II
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Class II
Pollen Allergy Test
Distribution without premarket approval/clearance.
Class II
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Fresenius Kabi USA, LLCdevice
Class II
Alcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
Class II
Gut Microbiome Test XL
Distribution without premarket approval/clearance.
Class II
Pet Allergy Test
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
Class II
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Class II
Urinary Tract Infection Test
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Lactose Intolerance Test
Distribution without premarket approval/clearance.
Class II
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
Paragon 28, Inc.device
Class II
PSA Test
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX850. Product Number: 866470.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Gut Microbiome Test Small
Distribution without premarket approval/clearance.
Class II
8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
Class II
Akkermansia Test
Distribution without premarket approval/clearance.
Class II
MAMMOMAT Inspiration;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II
Food Intolerance Test Medium
Distribution without premarket approval/clearance.
Class II
MAMMOMAT Fusion;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II
IntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Food Sensitivity Test Large
Distribution without premarket approval/clearance.
Class I — Urgent
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Fresenius Kabi USA, LLCdevice
Class II
Mycotoxin Panel Test
Distribution without premarket approval/clearance.
Class II
Food Sensitivity Test Small
Distribution without premarket approval/clearance.
Class II
Allergy test Small
Distribution without premarket approval/clearance.
Class II
Peptic Ulcer Test (H, pylori)
Distribution without premarket approval/clearance.
Class II
Heavy Metals Test
Distribution without premarket approval/clearance.
Class II
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Class II
Fructose Intolerance Test
Distribution without premarket approval/clearance.
Class II
Trichomonas Vaginalis test
Distribution without premarket approval/clearance.
Class II
IntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
SIBO Test
Distribution without premarket approval/clearance.
Class II
IntelliVue MP80. Product Number: M8008A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
IntelliVue Patient Monitor MX100. Product Number: 867033.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Intestinal Worms Test
Distribution without premarket approval/clearance.
Class II
D-Dimer Test
Distribution without premarket approval/clearance.
Class II
IntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Diabetes HbA1c Test
Distribution without premarket approval/clearance.
Class II
Olympus OER-Elite
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Aizu Olympus Co., Ltd.device
Class II
Candida Test
Distribution without premarket approval/clearance.
Class II
Syphilis Test
Distribution without premarket approval/clearance.
Class II
Iodine Test
Distribution without premarket approval/clearance.
Class II
MPOX Test
Distribution without premarket approval/clearance.
Class II
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Medtronic, Inc.device
Class II
GI Microbiome Profile Small
Distribution without premarket approval/clearance.
Class II
Parasite Test
Distribution without premarket approval/clearance.
Class II
Sperm Test
Distribution without premarket approval/clearance.
Class II
DHEA Test
Distribution without premarket approval/clearance.
Class II
Serotonin Test
Distribution without premarket approval/clearance.
Class II
Female Fertility Test
Distribution without premarket approval/clearance.
Class II
Gut Microbiome Test Mega
Distribution without premarket approval/clearance.
Class II
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Food Allergy Panel Test (IgE)
Distribution without premarket approval/clearance.
Class II
Food Intolerance Test Large
Distribution without premarket approval/clearance.
Class II
NAD Profile Test
Distribution without premarket approval/clearance.
Class II
Vitamin D2 and D3 Test
Distribution without premarket approval/clearance.
Class II
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Enterix, Inc.device
Class II
Leaky Gut Test
Distribution without premarket approval/clearance.
Class II
Kidney Test
Distribution without premarket approval/clearance.
Class II
2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
Class II
Menopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
Class II
Blood Type Test
Distribution without premarket approval/clearance.
Class II
3 in 1 STI Test
Distribution without premarket approval/clearance.
Class II
IntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Biological Age & Longevity Test
Distribution without premarket approval/clearance.
Class II
Lyme Test
Distribution without premarket approval/clearance.
Class II
Drug Test Small (4 substances)
Distribution without premarket approval/clearance.
Class II
IntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Organic acids Test
Distribution without premarket approval/clearance.
Class II
IntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Hair Mineral Analysis
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX600. Product Number: 865242.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Gut Microbiome Test Large
Distribution without premarket approval/clearance.
Class II
Chlamydia Test
Distribution without premarket approval/clearance.
Class II
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Illumina, Inc.device
Class II
Gonorrhea test
Distribution without premarket approval/clearance.
Class II
Cholesterol Test
Distribution without premarket approval/clearance.
Class II
Iron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
Class II
Thyroid TSH Test
Distribution without premarket approval/clearance.
Class II
Herpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
Class II
Iron Deficiency Test
Distribution without premarket approval/clearance.
Class II
Diabetes Test (ketones & glucose)
Distribution without premarket approval/clearance.
Class II
Liver Test
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX400. Product Number: 866060.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Pregnancy Test
Distribution without premarket approval/clearance.
Class II
Allergy & Food Intolerance Test
Distribution without premarket approval/clearance.
Class II
Ovulation Test (5 tests)
Distribution without premarket approval/clearance.
Class II
IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Class II
Food Sensitivity Test Medium
Distribution without premarket approval/clearance.
Class II
Olympus OER-Pro
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Aizu Olympus Co., Ltd.device
Class II
Men s Hormone Test
Distribution without premarket approval/clearance.
Class II
H pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
Class II
MAMMOMAT Revelation;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Class II
IntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Neurotransmitters Basic
Distribution without premarket approval/clearance.
Class II
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
Class II
Fecal Occult Blood Test
Distribution without premarket approval/clearance.
Class II
IntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Women s Hormone Test
Distribution without premarket approval/clearance.
Class II
Melatonin Test
Distribution without premarket approval/clearance.
Class II
Olympus OER-Mini
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Aizu Olympus Co., Ltd.device
Class II
IntelliVue Patient Monitor MX450. Product Number: 866062.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Neurotransmitters XL
Distribution without premarket approval/clearance.
Class II
IBS Test
Distribution without premarket approval/clearance.
Class II
Sorbitol Intolerance Test
Distribution without premarket approval/clearance.
Class II
Environmental Pollutants Profile Test
Distribution without premarket approval/clearance.
Class II
Vaginal PH Test
Distribution without premarket approval/clearance.
Class II
Gut Microbiome Test Medium
Distribution without premarket approval/clearance.
Class II
Estrogen & Progesterone Test
Distribution without premarket approval/clearance.
Class II
IntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Continuous Glucose Monitor (CGM)
Distribution without premarket approval/clearance.
Class II
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Class II
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
Cepheiddevice
Class II
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Stryker Corporationdevice
Class II
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Potential for anesthesia leakage.
Class II
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Stryker Corporationdevice
Class II
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Class II
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Straumann USA LLCdevice
Class II
CareLink Clinic, REF: MMT-7350
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Medtronic MiniMed, Inc.device
Class II
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Potential for anesthesia leakage.
Class II
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1
XXX
Alcon Research LLCdevice
Class II
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Class II
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
Class II
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
DJO, LLCdevice
Class II
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.