TAS Medical Inc: Medical Device Recall in 2025 - (Recall #: Z-1294-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

Product Classification:

Class II

Date Initiated: January 27, 2025

Date Posted: March 12, 2025

Recall Number: Z-1294-2025

Event ID: 96274

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.

Status: Ongoing

Product Quantity: 114

Code Information:

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated