Class II — Boston Scientific Neuromodulation 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 | Sterile anchors my lack sterility assurance. |
| Product | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 |
| Quantity | 43 units |
| Distribution | US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK. |
| Initiated | 2026-04-29 |
| Classified | 2026-06-11 |
| Recall number | Z-2404-2026 |
| 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 Neuromodulation Corporation (Z-2404-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98941/
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