TISSUE APPROXIMATION SYSTEM — Class II medical device recall Z-1294-2025
Ongoing recall by TAS Medical Inc, reported 2025-03-12, distributed nationwide. Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim
| Recall number | Z-1294-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TAS Medical Inc, Windermere, FL, United States |
| Recall initiated | 2025-01-27 |
| Classified | 2025-03-06 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 114 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00197644217267, 00197644927241, 00860011435914, 00860011435921 |
| Lot numbers | T-LAP/00860011435914 |
| Model numbers | T-4000, T-5000 |
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Reason for recall
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.
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-1294-2025. 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.