Class II — COVIDIEN LLC
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection |
| Product | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND |
| Quantity | 2,180 units |
| Distribution | US Nationwide, Israel, and Japan |
| Initiated | 2020-01-17 |
| Classified | 2020-02-18 |
| Terminated | 2022-07-29 |
| Recall number | Z-1264-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — COVIDIEN LLC (Z-1264-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84811/
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