Artelon FlexBand Plus Ref: 41054 & 41057 — Class II medical device recall Z-1555-2026
Ongoing recall by International Life Sciences, reported 2026-03-18, distributed nationwide. Augmentation devices failed bacterial endotoxin testing.
| Recall number | Z-1555-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Life Sciences, Atlanta, GA, United States |
| Recall initiated | 2026-02-06 |
| Classified | 2026-03-11 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, DE, ES, FR, GB, IT, JP, KR, SI |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00850003396033, 00850003396064 |
| Lot numbers | A10010101, A10010201 |
| Model numbers | 41054, 41057 |
Product
Artelon FlexBand Plus Ref: 41054 & 41057
Reason for recall
Augmentation devices failed bacterial endotoxin testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1555-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.