FDA DevicesClass II
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Published: June 17, 2026Recall ID: Z-2404-2026Category: devicesCountry: US
Reason for Recall / Hazard
Sterile anchors my lack sterility assurance.
Product Description & Identification
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Affected Products
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Additional Source Details
| Field | Value |
|---|---|
| City | Valencia |
| State | CA |
| Event id | 98941 |
| Address 1 | 25155 Rye Canyon Loop |
| Address 2 | N/A |
| Code info | GTIN: 08714729905318/Lot # 35107836 |
| Postal code | 91355-5004 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 43 units |
| Reason for recall | Sterile anchors my lack sterility assurance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260429 |
| Initial firm notification | N/A |
| Center classification date | 20260611 |
Overview
- Recalling FirmBoston Scientific Neuromodulation Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.