Artelon FlexBand Plus Ref: 41054 & 41057
FDA Recall #Z-1555-2026 — Class II — February 6, 2026
Product Description
Artelon FlexBand Plus Ref: 41054 & 41057
Reason for Recall
Augmentation devices failed bacterial endotoxin testing.
Recalling Firm
International Life Sciences — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
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 Information
REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated