Artelon FlexBand Plus implants failed bacterial endotoxin testing
International Life Sciences is recalling Artelon FlexBand Plus, refs 41054 and 41057, because the augmentation devices failed bacterial endotoxin testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an implantable augmentation device failed a bacterial endotoxin test rather than merely lacking validation, and no injuries are stated in the source.
Plain-English summary
International Life Sciences is recalling the Artelon FlexBand Plus, refs 41054 and 41057. The product was distributed across 41 US states and to Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, the United Kingdom, the United Arab Emirates and Slovenia. The FDA has classified this recall as Class II.
The augmentation devices failed bacterial endotoxin testing.
Affected product covers ref 41054, lot A10010201, GTIN 00850003396064, and ref 41057, lot A10010101, GTIN 00850003396033.
Facilities can identify affected devices by the refs, lots and GTINs above, and may contact International Life Sciences for further information.
The recalled product
- Product
- Artelon FlexBand Plus Ref: 41054 & 41057
- Manufacturer
- International Life Sciences
- Hazard
- failed-endotoxin-testing
- contamination-risk
- implant
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22