FDAHealthFebruary 6, 2026

International Life Sciences — Artelon FlexBand Dynamic Matrix Ref: 31057

⚠️ 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 Dynamic Matrix Ref: 31057
Brand: International Life Sciences
Lot code: A10011001/GTIN: 00850003396019

Additional details

A10011001/GTIN: 00850003396019

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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