Palindrome RT Repair Kit 15 FR TAL 44cm — Class II medical device recall Z-2368-2021
Ongoing recall by Covidien, LP, reported 2021-09-08. This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancement
| Recall number | Z-2368-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2021-05-28 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Reason classes | labeling |
| Lot numbers | 1704700210, 1822600138, 1826200177 |
| Model numbers | 8888541144 |
Product
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Reason for recall
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2368-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.