ROTAWIRE Drive and wireClip Torquer — Class II medical device recall Z-0915-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-04-20. Pouch seals may be open, compromising sterility.
| Recall number | Z-0915-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2022-03-08 |
| Classified | 2022-04-12 |
| Reported by FDA | 2022-04-20 |
| Countries outside the US | CA, JP |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729996255 |
| Lot numbers | 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019, 27756205, 27756933, 27756935 |
Product
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Reason for recall
Pouch seals may be open, compromising sterility.
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-0915-2022. 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.