FDA Device recall Z-1294-2025
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP by Tas Medical, citing tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F ster….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1294-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-27 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tas Medical |
| Distribution | US |
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Reason
Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.
Identifiers
| code_info | Model/UDI-DI/Lot(Expiration): T-4000/00197644217267/230403(2024/04/20); T-5000/00860011435921/240801(2025/08/28), 2409…Model/UDI-DI/Lot(Expiration): T-4000/00197644217267/230403(2024/04/20); T-5000/00860011435921/240801(2025/08/28), 240901(2025/09/25); T-LAP/00860011435914, 00197644927241/240702(2025/07/08), 230906(2024/11/29), 230905(2024/11/29) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1294-2025%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.