Boston Scientific Model SC-4318 — Class II medical device recall Z-2404-2026
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2026-06-17, distributed nationwide. Sterile anchors my lack sterility assurance.
| Recall number | Z-2404-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2026-04-29 |
| Classified | 2026-06-11 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 43 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729905318 |
| Lot numbers | 35107836 |
| Model numbers | C-4318, M365SC43180 |
Product
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Reason for recall
Sterile anchors my lack sterility assurance.
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-2404-2026. 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.