FDA-Device2026-03-18Class IIPROCESSING DEFECT
Artelon FlexBand Plus augmentation devices recalled for bacterial endotoxin contamination
What this means
International Life Sciences is recalling Artelon FlexBand Plus augmentation devices (Ref: 41054 and 41057) because they failed bacterial endotoxin testing. These devices may contain harmful bacterial contamination that could cause infection or other complications if implanted.
- Stop using affected devices immediately if you have them in stock or in use
- Check the lot numbers: A10010201 (Ref: 41054) or A10010101 (Ref: 41057)
- Contact your healthcare provider or facility if you have had this device implanted
- Return unused devices to International Life Sciences or your supplier for instructions
The agency's original wording
Hazard
Augmentation devices failed bacterial endotoxin testing.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
N/A
Manufactured in
8601 Dunwoody Pl Ste 250, N/A, Atlanta, GA, United States
Products
Artelon FlexBand Plus Ref: 41054 & 41057
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1555-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.