Class II — TAS Medical Inc
| Recalling firm | TAS Medical, Inc. |
|---|---|
| Registered facility | TAS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP |
| Quantity | 114 |
| Distribution | US Nationwide distribution in the states of LA, OK, TN. |
| Initiated | 2025-01-27 |
| Classified | 2025-03-06 |
| Recall number | Z-1294-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TAS Medical Inc (Z-1294-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96274/
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