Z-2404-2026 Class II Ongoing
FDA device recall Z-2404-2026 was initiated by Boston Scientific Neuromodulation Corporation on April 29, 2026 and is designated Class II. Reason for recall: Sterile anchors my lack sterility assurance. The recall status is ongoing. Affected quantity: 43 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units
Product Description
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Reason for Recall
Sterile anchors my lack sterility assurance.
Distribution Pattern
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Code Information
GTIN: 08714729905318/Lot # 35107836