Covidien Tri-Staple 2 — Class II medical device recall Z-1419-2021
Terminated recall by Covidien Llc, reported 2021-04-21, distributed in AL, AR, FL, IN, LA, MA, MN, MO…. Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to
| Recall number | Z-1419-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2021-03-23 |
| Classified | 2021-04-13 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2024-05-15 |
| Distributed | AL, AR, FL, IN, LA, MA, MN, MO, NJ, NY, OR, PA, TX |
| Quantity | 222 units |
| Reason classes | chemical contamination, sterility |
| UPC / GTIN / UDI-DI | 20884521717623 |
| Lot numbers | N0M0801RY |
| Expiration dates | 2023-11-30 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1419-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.