2090 recalls distributed in Illinois
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign object (glass) found inside sealed container of finished product.
Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.
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.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign object (glass) found inside sealed container of finished product.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.
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.
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.
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.
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Potential Salmonella contamination
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.
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.
Positive Salmonella contamination
Potential contamination with listeria monocytogenes.
Undeclared egg
Potential contamination with listeria monocytogenes.
Product contains undeclared Yellow #5
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.
potential contamination with glass
Product may be contaminated with Salmonella
Product contains undeclared Yellow #5
Potential contamination with patulin.
Water was bottled under insanitary conditions.
Potential contamination with Salmonella.
Water was bottled under insanitary conditions.
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.
Water was bottled under insanitary conditions.
Potential to be contaminated with Salmonella
Label declares bovine colostrum but does not declare milk allergen.
foreign material (small hard plastic fragments)
Foreign material. During production, the firm found pieces of blue plastic in a filter.
Foreign material. During production, the firm found pieces of blue plastic in a filter.
Undeclared Aspartame
Undeclared hazelnut.
Foreign material. During production, the firm found pieces of blue plastic in a filter.
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
Imported oysters potentially contaminated with Norovirus
Under-processed product may contain pathogenic bacteria that could harm to humans.
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
Under-processed product may contain pathogenic bacteria that could harm to humans.
Undeclared Milk Allergen
Under-processed product may contain pathogenic bacteria that could harm to humans.
potential Clostridium botulinum contamination
Under-processed product may contain pathogenic bacteria that could harm to humans.
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
Undeclared Milk Allergen
Undeclared Milk Allergen
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.
potential Clostridium botulinum contamination
Product contains salt and is mislabeled
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.
Product contains undeclared milk and egg
Product contains salt and is mislabeled
Under-processed product may contain pathogenic bacteria that could harm to humans.
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
Product contains salt and is mislabeled
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Products may be contaminated with Salmonella Typhimurium
Products may be contaminated with Salmonella Typhimurium
Mold contamination detected for raw material lots that were produced in July and used in finished goods.
Undeclared allergens (milk and soy).
Potential undeclared allergen ingredient (Wheat)
elevated levels of chloramphenicol in frozen shrimp
Undeclared soy lecithin
Foreign material
Undeclared soy lecithin
Potential undeclared allergen ingredient (Wheat)
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Clear hard plastic fragments.
Product found to contain leachable lead levels.
Product tested positive for Listeria Monocytogenes.
May contain partially hydrogenated oils
Clear hard plastic fragments.
Shrimp may be contaminated with Cesium-137 (Cs-137).
pathogen Cyclospora cayetanensis
Product tested positive for Listeria Monocytogenes.
May contain partially hydrogenated oils
Product tested positive for Listeria Monocytogenes.
Floating black foreign substance in the product
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Shrimp may be contaminated with Cesium-137 (Cs-137).
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Product tested positive for Listeria Monocytogenes.
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Product tested positive for Listeria Monocytogenes.
Foreign material.
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Undeclared wheat
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Undeclared allergen - milk
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Undeclared pecan
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Contaminated with Salmonella
Contaminated with Salmonella
Plastic fragments. Pieces of semi-rigid plastic embedded in the recalled Tater Gems product.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Product may be contaminated with Salmonella
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Contaminated with Clostridium botulinum
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Product may contain food-grade cleaning agents
Potential metal fragments from supplier raw material (downstream recall)
Potential contamination with Listeria monocytogenes.
Potential metal fragments from supplier raw material (downstream recall)
Undeclared Soy
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
foreign objects (black plastic planting material) in granulated onion
Potential metal fragments from supplier raw material (downstream recall)
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
foreign objects (black plastic planting material) in granulated onion
Products do not declare milk in the Contains statement or the ingredient statement.
Potential metal fragments from supplier raw material (downstream recall)
Products do not declare milk in the Contains statement or the ingredient statement.
Potential metal fragments from supplier raw material (downstream recall)
Potential metal fragments from supplier raw material (downstream recall)
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
Potential metal fragments from supplier raw material (downstream recall)
Undeclared allergens - wheat and soy
Products contain undeclared shrimp (crustacean shellfish)
Wheat and Soy missing allergens from the product Contains Statement.
Peaches provided by Moonlight Peaches potentially contaminated with Listeria.
Products contains Magnesium Salicylate.
Peaches provided by Moonlight Peaches potentially contaminated with Listeria.
Products contains Magnesium Salicylate.
Product has the potential to be contaminated with Salmonella
Product has the potential to be contaminated with Salmonella
Potential contamination with Listeria monocytogenes
Products contains Magnesium Salicylate.
Product has the potential to be contaminated with Salmonella
Product has the potential to be contaminated with Salmonella
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Products may contain elevated levels of lead.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
Shrimp may be contaminated with Cesium-137 (Cs-137).
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Potential foreign material (plastic)
Undeclared Peanuts. The firm received two complaints that the product contains peanuts which are not listed in the ingredient statement.
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Possible presence of stones in product
Possible presence of stones in product
Store-made deli items contain a pasta ingredient that was recalled due to potential Listeria monocytogenes
Store-made deli items contain a pasta ingredient that was recalled due to potential Listeria monocytogenes
Possible presence of stones in product
Product contains undeclared egg, FD&C Yellow 5, and FD&C Yellow 6.
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
Contains Linguine manufactured by Nate's Fine Foods LLC recalled for Listeria monocytogenes and implicated in ongoing outbreak
Potential Listeria monocytogenes contamination.
Contaminated with Listeria monocytogenes
Potential contamination with heavy metal (Lead).
Contains elevated levels of lead
Potential Listeria monocytogenes contamination.
Potential Listeria monocytogenes contamination.
Potential contamination with heavy metal (Lead).
Potential Listeria monocytogenes contamination.
Potential Listeria monocytogenes contamination.
Potential Listeria monocytogenes contamination.
Potential Listeria monocytogenes contamination.
Potential Listeria monocytogenes contamination.
Potential contamination with heavy metal (Lead).
Potential contamination with heavy metal (Lead).
Potential Listeria monocytogenes contamination.
Potential Listeria monocytogenes contamination.
Contaminated with Listeria monocytogenes
Product may contain undeclared shrimp (crustacean shellfish).
Potential Listeria monocytogenes contamination.
Undeclared pine nut
Potential contamination with foreign objects.
No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashews, wheat, soy, and sesame)
No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)
detectable pyrrolizidine alkaloids
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.
Potential yeast contamination.
contains undeclared wheat
Product label contains conflicting statements about inclusion and being free of Soy ingredient.
Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts.
Undeclared allergens (cashews).
Undeclared allergens (milk).
Unapproved Drug Claims and Misbranded.
Product may be contaminated with Cesium-137 (Cs-137).
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Product may be contaminated with Cesium-137 (Cs-137).
Product may be contaminated with Cesium-137 (Cs-137).
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Undeclared Yellow #5 and Yellow #6.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Undeclared Yellow #5 and Yellow #6.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Goldband Snapper is recalled because testing confirmed fish is Sharptooth Snapper.
Potential for spoilage due to yeast contamination.
Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
Product may be contaminated with Cesium-137 (Cs-137)
Product may be contaminated with Cesium-137 (Cs-137)
Product may be contaminated with Cesium-137 (Cs-137)
Product tested positive Salmonella .
Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.
Product may be contaminated with Cesium-137 (Cs-137)
Product tested positive Salmonella .
undeclared almond, walnut, and pecan.
Product contains undeclared soy lecithin.
Product label includes the ingredient CREAM but does not include Milk as the source.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Potential contamination with foreign objects (metal pieces).
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Potential contamination with Listeria monocytogenes.
Potential presence of glass pieces
Potential contamination with foreign objects (metal pieces).
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
foreign material (plastic)
Potential contamination with foreign objects (metal pieces).
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with foreign objects (metal pieces).
Potential contamination with Listeria monocytogenes.
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Product label includes the ingredient CREAM but does not include Milk as the source.
Potential contamination with Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Potential contamination with Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Product label includes the ingredient CREAM but does not include Milk as the source.
Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
Product may have small flakes of stainless steel in product.
Supplier recalled ingredient used in finished product for possible Listeria monocytogenes contamination
Pecans have the potential to be contaminated with Salmonella
Product may have small flakes of stainless steel in product.
Pecans have the potential to be contaminated with Salmonella
Pecans have the potential to be contaminated with Salmonella
Product may have small flakes of stainless steel in product.
Pecans have the potential to be contaminated with Salmonella
Pecans have the potential to be contaminated with Salmonella
Pecans have the potential to be contaminated with Salmonella
Foreign Material (wood)
Undeclared wheat and soy
Undeclare Tree Nuts (almond, macadamia nut)
potential Listeria Monocytogenes Contamination
potential Listeria Monocytogenes Contamination
potential Listeria Monocytogenes Contamination
Undeclared wheat
potential Listeria Monocytogenes Contamination
Undeclared wheat and soy
potential Listeria Monocytogenes Contamination
Undeclared wheat and soy
potential Listeria Monocytogenes Contamination
Undeclared wheat and soy
Undeclared wheat and soy
Undeclared wheat
Undeclared wheat and soy
Undeclared wheat
Undeclared wheat and soy
Undeclared wheat
Undeclared wheat
potential Listeria Monocytogenes Contamination
potential Listeria Monocytogenes Contamination
Undeclared wheat
potential Listeria Monocytogenes Contamination
potential Listeria Monocytogenes Contamination
Undeclared wheat
Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
Undeclared wheat
Undeclared wheat and soy
potential Listeria Monocytogenes Contamination
Undeclared wheat and soy
potential Listeria Monocytogenes Contamination
potential Listeria Monocytogenes Contamination
Undeclared wheat
Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
Undeclared wheat and soy
Undeclared Milk
Undeclared wheat and soy
Undeclared wheat and soy
Undeclared wheat and soy
Undeclared wheat
Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.
potential Listeria Monocytogenes Contamination
potential Listeria Monocytogenes Contamination
Undeclared wheat
Undeclared allergens (Peanut) due to mispackaging
Undeclared allergens (Peanut) due to mispackaging
Undeclared allergen: Hazelnut due to mispackaging. Product with hazelnuts was put in the Artisan Style 1/2 loaf bags. Bags do not have allergen statement that includes hazelnuts.
Undeclared allergens (Peanut) due to mispackaging
Individual consumer size Wasabi mini pack label does not declare allergen ingredient Yellow 5.
Undeclared allergens (Peanut) due to mispackaging
Foreign material (plastic pieces)
Potential Listeria Monocytogenes Contamination
Foreign material (plastic pieces)
undeclared pecans
Foreign material (plastic pieces)
Potential Listeria Monocytogenes Contamination
"Wood-Ear" mushroom tested positive for Salmonella.
contaminated with Bacillus cereus and may be spoiled
Potential Listeria Monocytogenes Contamination
Foreign material (plastic pieces)
undeclared pecans
Foreign material (plastic pieces)
Potential Listeria Monocytogenes Contamination
Potential Listeria Monocytogenes Contamination
Foreign material (plastic pieces)
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Subpotent Drug
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed tablet specifications.
Failed Tablet/Capsule Specifications
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
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.
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.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
CGMP Deviations
CGMP Deviations
Defective container; inadequately sealed blister packaging.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
CGMP Deviations
CGMP Deviations
CGMP Deviations
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
CGMP Deviations
CGMP Deviations
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
CGMP Deviations
CGMP Deviations
Stability Data Does Not Support Expiry Date.
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Failed Dissolution Specifications
Presence of Particulate Matter: Due to production issues
Failed Dissolution Specifications
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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.
Presence of Foreign substance - potential presence of metal particulate matter
cGMP deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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.
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Lack of Assurance of Sterility
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Lack of Assurance of Sterility
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Tablets/Capsules Imprinted with Wrong ID
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Lack of Assurance of Sterility
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Defective Delivery System: Missing or duplicated needles within the injection kit
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
cGMP deviations
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Presence of Foreign Tablets/Capsules
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Failed Impurities/Degradation Specifications
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.
Failed PH Specifications
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.
Presence of Foreign Substance
Subpotent Drug
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
cGMP deviations.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Presence of Particulate Matter.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Presence of particulate matter - Glass like particles.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Out of specification for dissolution.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Presence of particulate matter - Glass like particles.
Presence of particulate matter - Glass like particles.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
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.
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of Particulate Matter: Hair was found in a prefilled syringe
Lack of Assurance of Sterlity
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of Foreign Tablets/Capsules
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Failed stability specifications: Out of specification for hardness test
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Defective container - seal not adhering to bottles
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed stability specifications: Out of specification for hardness test
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cross Contamination with Other Products
Incorrect Product Formulation
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
cGMP deviations
cGMP deviations
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
cGMP deviations
cGMP deviations
cGMP deviations
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
cGMP deviations
Defective Container - A defect in the side-seal which allows leakage of product.
cGMP deviations
Failed Stability Specifications: Observed OOS results: eg results for colour index
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Dissolution Specifications
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Subpotent Drug
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
CGMP Deviations: Potential presence of metal particulate matter
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.
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.
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.
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Defective Container
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.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
CGMP Deviations: Potential presence of metal particulate matter
Lack of Assurance of Sterility: Potential for flexible container leaks.
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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.
Product Mix-up
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: Potential presence of metal particulate matter
Presence of Particulate Matter
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.
CGMP Deviations: Potential presence of metal particulate matter
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.
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.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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.
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed Tablet/Capsule Specifications
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Tablet/Capsules Imprinted with Wrong ID
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Subpotent Drug
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Tablet/Capsules Imprinted with Wrong ID
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Presence of Particulate Matter: Particulate matter identified as glass
Lack of Assurance of Sterility.
Failed Dissolution Specifications
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).
Discoloration
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Dissolution Specifications
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.
Lack of Assurance of Sterility:
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Failed Dissolution Specifications
Failed Dissolution Specifications
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Content Uniformity Specifications
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Microbial Contamination of Sterile Products: elevated endotoxin levels
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Failed Dissolution Specifications.
CGMP Deviations: Market complaints received for gritty texture (grainy)
Cross Contamination with Other Products.
Cross Contamination with Other Products.
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Subpotent drug
Failed Impurities/Degradation Specifications:
Lack of Assurance of Sterility
Failed Impurity/Degradation Specifications
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.
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.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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.
Superpotent drug
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
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.
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).
Failed Impurity/Degradation Specifications
cGMP deviations: Temperature excursion during transportation.
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.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Presence of a foreign substance.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Presence of a foreign substance.
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.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
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.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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.
Subpotent Drug
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Presence of Particulate Matter.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Subpotent Drug
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.
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.
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.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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.
Subpotent Drug
Presence of Particulate Matter
Subpotent Drug
Subpotent Drug
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Discoloration
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
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.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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
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.
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Discoloration
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Failed Dissolution Specifications: low dissolution results
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.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Presence of foreign substance: identified as aluminum.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
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.
CGMP Deviations; particulates identified during visual inspection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
CGMP Deviations; particulates identified during visual inspection
Failed Dissolution Specifications.
Sub-Potent Drug: Subpotent assay results during stability testing.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
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.
Subpotent Drug: Assay below the approved specification
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug: Assay below the approved specification
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
CGMP Deviations
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).
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
CGMP Deviations
Subpotent Drug: Assay below the approved specification
CGMP Deviations
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug: Assay below the approved specification
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
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
Failed Impurity/Degradation Specifications
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
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
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Defective container; blister packaging inadequately sealed.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Failed Impurity/Degradation Specifications
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Defective container; blister packaging inadequately sealed.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of foreign tablets/capsules.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Discoloration; discolored solution from cracked vials
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Failed Dissolution Specifications
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
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.
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
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.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Presence of a foreign substance: black hair found embedded in tablet.
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.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
cGMP deviations
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
OOS results reported for the Dissolution (by UV) test.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Failed Impurities/Degradation Specifications
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Defective delivery system
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
cGMP deviations
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
cGMP deviations
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
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.
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.
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Lack of Assurance of Sterility
CGMP Deviations
cGMP deviations and lack of assurance of sterility.
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.
Presence of Particulate Matter
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Subpotent
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Subpotent
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
cGMP Deviations
Subpotent
Subpotent
Lack of Assurance of Sterility: Leaking/damaged syringes.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of Assurance of Sterility: Leaking/damaged syringes.
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.
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of Assurance of Sterility: Leaking/damaged syringes.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
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.
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
CGMP Deviations
CGMP Deviations
Cross Contamination
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
CGMP Deviations
Chemical contamination: Presence of benzene
CGMP Deviations
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of Particulate Matter
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Cross Contamination
CGMP Deviations
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
Chemical contamination: Presence of benzene
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed dissolution specifications: lower than specifications
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Presence of Foreign Tablets/Capsules.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Presence of foreign substance: Presence of Benzene.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Lack of Assurance of Sterility
Presence of foreign substance: Presence of Benzene.
Chemical contamination: presence of benzene
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Failed Dissolution Specifications - low dissolution results
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
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Subpotent Drug
Subpotent Drug
Chemical contamination: presence of benzene
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Failed Dissolution Specifications
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Chemical Contamination: Presence of benzene.
Chemical Contamination
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Presence of Particulate Matter
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Chemical Contamination: Presence of benzene
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.
Chemical Contamination
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Failed Impurities/Degradation Specifications
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
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.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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%)
Presence of Particulate Matter.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Out of Specification for Dissolution
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Failed Dissolution Specifications.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
CGMP Deviations: lack of adequate release testing.
CGMP Deviations; product intended for quarantine was inadvertently distributed
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Failed Dissolution Specifications:
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Presence of Foreign Tablets/Capsules
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Non-Sterility
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
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
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Failed Stability Specifications
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
CGMP Deviations
Presence of Foreign Tablets/Capsules
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
LABELING: LABEL MIX-UP
Crystallization
Failed Dissolution Specifications
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Failed Impurities/Degradation Specifications
Crystallization
LABELING: LABEL MIX-UP
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
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.
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.
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.
Discoloration
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.
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.
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.
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.
Lack of Sterility Assurance
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.
CGMP deviations: out of specifications for assay
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.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
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.
Failed Impurities/Degradation Specifications
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.
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.
Lack of Sterility Assurance
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
CGMP Deviations: Released product should have been rejected.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Failed Impurities/Degradation Specifications
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
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).
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Labeling: Label Mix-Up
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Subpotent drug
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
cGMP Deviations: Out of specification results for micro in hand soap products.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Labeling: Not Elsewhere Classified - Wrong NDC number
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
cGMP Deviations: Out of specification results for micro in hand soap products.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
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.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Probes may rupture/burst during activation
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
Probes may rupture/burst during activation
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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.
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.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
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.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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.
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).
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
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.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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.
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.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
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.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
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.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
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.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Probes may rupture/burst during activation
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Due to the likely presence of contamination in well(s).
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.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
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.
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.
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.
Due to adapter not being properly aligned or locked in place.
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.
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Drainable large pouch may leak due to manufacturing issue.
Drainable large pouch may leak due to manufacturing issue.
Labeling mix-up resulting in the incorrect lot outer packaging of product.
Cribs sold in the USA are missing two access door warning labels.
Due to product exhibiting potential to generate either invalid or false negative results.
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.
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
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.
Drainable large pouch may leak due to manufacturing issue.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The device does not bear a unique device identifier.
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.
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
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.
Augmentation devices failed bacterial endotoxin testing.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.
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.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.
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.
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.
Impactor handle may be missing cross-pin
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
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.
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.
Due to pediatric defibrillator electrode delamination
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
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.
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.
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.
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.
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.
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.
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.
Augmentation devices failed bacterial endotoxin testing.
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Augmentation devices failed bacterial endotoxin testing.
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.
The device does not bear a unique device identifier.
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.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The device does not bear a unique device identifier.
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.
The device does not bear a unique device identifier.
Product not cleared by the FDA.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
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.
Impactor handle may be missing cross-pin
The device does not bear a unique device identifier.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.
Reports of devices sparking/popping and potentially burning patients.
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.
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.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Product not cleared by the FDA.
The device does not bear a unique device identifier.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Product not cleared by the FDA.
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.
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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Potential for rubber fragment detachment during use.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Potential for rubber fragment detachment during use.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
There is the potential for the length of the trocar shaft to be too long.
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.
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.
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,
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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.
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.
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.
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.
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.
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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Knee and Humeral socket implants contain incorrect labeling.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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.
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.
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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Knee and Humeral socket implants contain incorrect labeling.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Lack of 510K clearance
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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.
Knee and Humeral socket implants contain incorrect labeling.
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 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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Lack of 510K clearance
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.
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.
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.
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.
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.
Due to damage to outer tray that can potentially compromise the sterile barrier
Potential packaging failures, which could lead to a breach in the sterile barrier.
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.
Firm is initiating a removal due to continued reports of adverse events.
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.
Firm is initiating a removal due to continued reports of adverse events.
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 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.
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.
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.
Firm is initiating a removal due to continued reports of adverse events.
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.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Issue with software algorithm which may lead to overpressure events.
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.
Firm is initiating a removal due to continued reports of adverse events.
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 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 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 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.
Issue with software algorithm which may lead to overpressure events.
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 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 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 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 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 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 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.
Firm is initiating a removal due to continued reports of adverse events.
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 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.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
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 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 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.
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.
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 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 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.
Potential packaging failures, which could lead to a breach in the sterile barrier.
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 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.
Issue with software algorithm which may lead to overpressure events.
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 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 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 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 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 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 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 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 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 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 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.
Products were mislabeled as the 6mm product but included the 5 mm product.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
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 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.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
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.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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.
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.
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
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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
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.
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.
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.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Tyvek bag seal issue which may compromise sterility of the kit.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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.
Due a design issue where the navigated array connection geometry is incorrect.
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
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
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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.
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.
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.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Due a design issue where the navigated array connection geometry is incorrect.
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.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
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, 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, 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.
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, 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, 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.
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, 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.
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.
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.
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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).
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.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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.
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.
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.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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.
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).
Devices which did not undergo thermoforming could deform and lose performance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Devices which did not undergo thermoforming could deform and lose performance.
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.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Devices which did not undergo thermoforming could deform and lose performance.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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.
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.
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.
Devices which did not undergo thermoforming could deform and lose performance.
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.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
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.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Devices which did not undergo thermoforming could deform and lose performance.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
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).
Devices which did not undergo thermoforming could deform and lose performance.
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).
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.
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.
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.
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.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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).
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.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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.
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.
Devices which did not undergo thermoforming could deform and lose performance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
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.
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.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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.
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.
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).
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
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.
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.
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.
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.
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.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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.
Devices which did not undergo thermoforming could deform and lose performance.
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.
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).
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
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.
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.
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.
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
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.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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 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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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 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 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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Potential exposure of rodents and rodent activity in the distribution center.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Incorrect expiration date
Potential exposure of rodents and rodent activity in the distribution center.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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.
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
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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 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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Potential exposure of rodents and rodent activity in the distribution center.
Incorrect expiration date
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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
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.
Potential exposure of rodents and rodent activity in the distribution center.
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
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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.
Potential exposure of rodents and rodent activity in the distribution center.
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.
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
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.
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.
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
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.
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
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.
Inflation device handle may detach from the syringe during procedure.
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.
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.
Inflation device handle may detach from the syringe during procedure.
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.
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.
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.
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
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.
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.
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).
Potential for fraying on the body support strap.
Inflation device handle may detach from the syringe during procedure.
Inflation device handle may detach from the syringe during procedure.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Potential for fraying on the body support strap.
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.
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.
The console label for affected devices is missing the "DANGER" symbol.
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.
Inflation device handle may detach from the syringe during procedure.
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.
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.
Inflation device handle may detach from the syringe during procedure.
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.
Due to products not having FDA Premarket authorization to be distributed within the United States.
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Inflation device handle may detach from the syringe during procedure.
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.
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
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.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
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).
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
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.
Potential for fraying on the body support strap.
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.
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.
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
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
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.
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.
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Labeling error, Incorrect expiration date
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.
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.
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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.
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.
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.
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.
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.
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.
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 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.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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.
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.
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.
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.
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.
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.
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.
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.
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Fungal contamination of affected lot with Parengyodontium album.
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.
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.
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.
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.
Emphasizing instructions for LVP duration programming located in the IFU.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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.
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.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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 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.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
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.
Potential for microbial contamination.
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.
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.
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.
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.
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 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 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 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.
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.
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.
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.
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.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
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.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
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.
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.
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.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Customer complaints of Pressio monitor rebooting.
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.
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 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.
Devices are not suitable for organ transplant.
Devices are not suitable for organ transplant.
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.
The affected lots show a decline in performance over time, which may lead to false-negative results.
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.
Devices are not suitable for organ transplant.
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.
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.
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.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
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.
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).
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Butyrate tube cracks during actuation, rendering product unusable.
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
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.
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.
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.
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.
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.
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.
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.
A certain component of affected devices was not delivered within specification and contained impurities.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
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
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.
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.
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.
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.
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.
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.
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.
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.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
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.
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.
Safety and efficacy of dialysis acid concentrate cannot be assured
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.
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.
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.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Safety and efficacy of dialysis acid concentrate cannot be assured
Ophthalmic procedure packs may have incomplete seals affecting sterility.
A certain component of affected devices was not delivered within specification and contained impurities.
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.
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.
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.
Safety and efficacy of dialysis acid concentrate cannot be assured
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Removal of affected lot of screws due to labeling error.
Recalled lots were manufactured with double the amount of preservative concentration.
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
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.
Potential for incomplete seal on header bag.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Potential for incomplete seal on header bag.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Potential for incomplete seal on header bag.
Potential for incomplete seal on header bag.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
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.
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
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.
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.
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.
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.
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.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Potential for incomplete seal on header bag.
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.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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).
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).
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Labeling contains claims that are not consistently present.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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.
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.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
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.
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.
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.
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, 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.
Screw may loosen or fallout of Hemodialysis system
Labeling contains claims that are not consistently present.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
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.
Distribution without premarket approval/clearance.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
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.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
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.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
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.
Distribution without premarket approval/clearance.
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.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
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.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
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.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
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.
Distribution without premarket approval/clearance.
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
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.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Potential issue where the IntelliVue monitors did not alarm.
Distribution without premarket approval/clearance.
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
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.
Product testing did not meet expected stability criteria.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Potential for anesthesia leakage.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
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
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
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.
Potential for anesthesia leakage.
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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.
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.
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.
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.