WhichRecall
Class IIReported 2026-03-18

Artelon FlexBand Plus Ref: 41054 & 41057

Recalled by International Life Sciences

Reason for Recall

Augmentation devices failed bacterial endotoxin testing.

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Recall Number
Z-1555-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-02-06
Reported
2026-03-18
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Code Info
REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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