# FDA recall Z-1419-2021

> **Covidien Llc** · Class II · device recall initiated 2021-03-23.

## Product

Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.  Product Number: SIGTRSB60AMT

## Reason for recall

Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch

## Distribution

AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX

## Key facts

- **Recall number:** Z-1419-2021
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-23
- **Report date:** 2021-04-21
- **Termination date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1419-2021

## Citation

> AI Analytics. FDA recall Z-1419-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1419-2021. Source: US FDA. Licensed CC0.

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