Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use Recalled by Covidien Llc Due to Potential for the pouch to contain an extra...

Date: March 23, 2021
Company: Covidien Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Covidien Llc directly.

Affected Products

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

Quantity: 222 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 13 states: AL, AR, FL, IN, LA, MA, MN, MO, NJ, NY, OR, PA, TX

Affected (13 states)Not affected

About Covidien Llc

Covidien Llc has 59 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report