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 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| Product | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 |
| Quantity | N/A |
| Distribution | Worldwide distribution. |
| Initiated | 2021-05-28 |
| Classified | 2021-08-27 |
| Recall number | Z-2364-2021 |
| 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-2364-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88250/
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