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 | Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained. |
| Product | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 |
| Quantity | 504 devices |
| Distribution | Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution. |
| Initiated | 2021-12-06 |
| Classified | 2022-01-13 |
| Terminated | 2023-05-11 |
| Recall number | Z-0495-2022 |
| 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-0495-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89182/
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