Gelweave — Class II medical device recall Z-2266-2014
Terminated recall by Vascutek, Ltd., reported 2014-08-27, distributed nationwide. The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its labe
| Recall number | Z-2266-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascutek, Ltd., Inchinnan, United Kingdom |
| Recall initiated | 2014-07-15 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 63,162 |
| Reason classes | labeling |
Product
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Reason for recall
The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).
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-2266-2014. 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.