FDA Device recall Z-2543-2021
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches by Vascutek, citing the devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2543-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-08 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vascutek |
| Distribution | PR |
Product
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Reason
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Identifiers
| code_info | To be reported. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2543-2021%22
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