FDA Device recall Z-1555-2026
Artelon FlexBand Plus Ref: 41054 & 41057
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Artelon FlexBand Plus Ref: 41054 & 41057 by International Life Sciences, citing augmentation devices failed bacterial endotoxin testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1555-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-06 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | International Life Sciences |
| Distribution | US |
Product
Artelon FlexBand Plus Ref: 41054 & 41057
Reason
Augmentation devices failed bacterial endotoxin testing.
Identifiers
| code_info | REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1555-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.