Gore Tips Set Device — Class II medical device recall Z-2249-2023
Ongoing recall by Creganna Medical Devices, reported 2023-08-09, distributed nationwide. Three lots of product may be labeled with an incorrect expiration day
| Recall number | Z-2249-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Creganna Medical Devices, Galway, N/A, Ireland |
| Recall initiated | 2023-06-22 |
| Classified | 2023-07-28 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 194 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05391526210000 |
| Lot numbers | 1V00099635, 1V00166928, 1V00199622 |
| Model numbers | TSET1016 |
Product
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Reason for recall
Three lots of product may be labeled with an incorrect expiration day
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-2249-2023. 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.