FDA Device recall Z-2249-2023
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access by Creganna Medical Devices, citing three lots of product may be labeled with an incorrect expiration day.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2249-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-22 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Creganna Medical Devices |
| Distribution | US |
Product
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Reason
Three lots of product may be labeled with an incorrect expiration day
Identifiers
| code_info | UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2249-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.