The FDA announced on March 23, 2021, that Covidien LLC voluntarily recalled its Tri-Staple 2.0 Reinforced Intelligent Reload stapling system due to potential sterility compromise. The hazard involves an extra laminate layer in the pouch that may affect gas de-gassing and increase infection risk.
How to tell if you have it
- Brand: Covidien
- Product: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement
- Product Number: SIGTRSB60AMT
- Lot Number: N0M0801RY
- Expiration Date: 11/30/2023
- UDI: A8845217176201 20884521717623
- Units affected: 222
- Sold in: AL, AR, FL, IN, LA, MA, MN, MO, NJ, NY, OR, PA, TX
The hazard
The recall addresses the potential for the pouch to contain an extra laminate layer, which may compromise device sterility. This inclusion can impact the complete de-gassing of Ethylene Oxide sterilization gas, resulting in a potentially increased risk for patient infection and/or exposure to retained Ethylene Oxide.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Other recent recalls of similar products include the Covidien EndoFLIP System recall (May 13, 2026), the Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026), and the Covidien Shiley Disposable Decannulation Plug Recall (April 23, 2026). Additional recent recalls include the Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), the DeRoyal Covaderm Plus Dressing Recall (May 18, 2026), and the Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026).