Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Pouch seals may be open, compromising sterility. |
| Product | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support |
| Quantity | 488 5-packs |
| Distribution | Distribution in the US and territories, Japan, and Canada |
| Initiated | 2022-03-08 |
| Classified | 2022-04-12 |
| Recall number | Z-0916-2022 |
| 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 — Boston Scientific Corporation (Z-0916-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89753/
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