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 | Ongoing |
| Reason | The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. |
| Product | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; |
| Quantity | 2448 units |
| Distribution | Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy; |
| Initiated | 2026-04-15 |
| Classified | 2026-06-01 |
| Recall number | Z-2281-2026 |
| 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-2281-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98871/
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.