Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection — Class II medical device recall Z-1264-2020
Terminated recall by COVIDIEN LLC, reported 2020-02-26, distributed nationwide. Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in
| Recall number | Z-1264-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2020-01-17 |
| Classified | 2020-02-18 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2022-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL, JP |
| Quantity | 2,180 units |
| Reason classes | sterility |
| Lot numbers | P9E0022Y |
Product
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Reason for recall
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
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-1264-2020. 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.