The Instructions for Use — Class II medical device recall Z-2543-2021
Terminated recall by Vascutek, Ltd., reported 2021-10-06, distributed in GU, PR. The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
| Recall number | Z-2543-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascutek, Ltd., Inchinnan, N/A, United Kingdom |
| Recall initiated | 2021-07-08 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2024-08-19 |
| Distributed | GU, PR |
| Quantity | 159 vascular |
Product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Reason for recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
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-2543-2021. 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.