Gelseal Straight Diameter 8mm Length 30cm — Class II medical device recall Z-1913-2015
Terminated recall by Vascutek, Ltd., reported 2015-07-08, distributed in MI. Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
| Recall number | Z-1913-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascutek, Ltd., Inchinnan, United Kingdom |
| Recall initiated | 2015-05-15 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-10-20 |
| Distributed | MI |
| Countries outside the US | AU, DE, GB, PL |
| Quantity | 12 |
| Reason classes | labeling |
| Lot numbers | 301509/02 |
| Serial numbers | 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215 |
Product
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Reason for recall
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
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-1913-2015. 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.