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 | Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices. |
| Product | LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. |
| Quantity | 936 |
| Distribution | Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom |
| Initiated | 2018-03-15 |
| Classified | 2018-07-12 |
| Terminated | 2019-12-11 |
| Recall number | Z-2427-2018 |
| 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-2427-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79735/
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