Medical device Recall: Artelon FlexBand Plus
Announced 2026-03-18 · FDA
The recall involves Artelon FlexBand Plus augmentation devices (REF 41054 and REF 41057). These augmentation devices failed bacterial endotoxin testing. Distribution was worldwide, including nationwide within the United States.
| Brand | International Life Sciences |
|---|---|
| Product | Artelon FlexBand Plus Ref: 41054 & 41057 |
| Reason | Augmentation devices failed bacterial endotoxin testing. |
| Severity | moderate |
| Units affected | 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. |
| Agency | FDA |
| Recall / campaign no. | REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033 |
WHAT YOU SHOULD DO
- If you own or use an Artelon FlexBand Plus device, contact your healthcare provider or the facility that supplied it for guidance.
- Do not remove or tamper with the device unless instructed by a healthcare professional.
- If you notice signs of infection or endotoxin-related issues (fever, redness, swelling, pain), seek medical attention promptly.
- Check your device documentation or contact the supplier to determine if you own one of the affected lots (41054 or 41057).
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.