Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT… — Class II medical device recall Z-2903-2026
Ongoing recall by TISSIUM SA, reported 2026-08-12, distributed nationwide. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to
| Recall number | Z-2903-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TISSIUM SA, Paris 12e Arrondissement, France |
| Recall initiated | 2026-06-15 |
| Classified | 2026-08-06 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, device malfunction |
| UPC / GTIN / UDI-DI | 03760279380094 |
| Lot numbers | 250700042, 251000033, 251000034 |
| Model numbers | NCOCO2010 |
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Reason for recall
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
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-2903-2026. 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.