Class II — Covidien
| 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 | Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable |
| Product | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD |
| Quantity | 47,901 units |
| Distribution | Worldwide distribution - US: Nationwide and surrounding territories. |
| Initiated | 2023-11-16 |
| Classified | 2024-01-03 |
| Recall number | Z-0631-2024 |
| 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 (Z-0631-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93561/
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