Covidien Llc: Medical Device Recall in 2021 - (Recall #: Z-1419-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 23, 2021

Date Posted: April 21, 2021

Recall Number: Z-1419-2021

Event ID: 87618

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

Status: Terminated

Product Quantity: 222 units

Code Information:

Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated