International Life Sciences — Artelon FlexBand Plus Ref: 41054 & 41057
⚠️ Augmentation devices failed bacterial endotoxin testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 6, 2026
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.
What's affected?
- Product
- Artelon FlexBand Plus Ref: 41054 & 41057
- Lot code
- A10010201/GTIN:
Additional details
REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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