# FDA recall Z-1294-2025

> **TAS Medical Inc** · Class II · device recall initiated 2025-01-27.

## 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.

## Distribution

US Nationwide distribution in the states of LA, OK, TN.

## Key facts

- **Recall number:** Z-1294-2025
- **Recalling firm:** TAS Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-27
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Windermere, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2025

## Citation

> AI Analytics. FDA recall Z-1294-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1294-2025. Source: US FDA. Licensed CC0.

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