Class II — Covidien, LP
| 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 device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure. |
| Product | Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV |
| Quantity | 11391 units WW: 5982 US 5409 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom. |
| Initiated | 2021-03-04 |
| Classified | 2021-04-09 |
| Terminated | 2024-07-12 |
| Recall number | Z-1384-2021 |
| 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, LP (Z-1384-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87475/
Alerts for Covidien llc
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.