FDA Enforcement
Class II
Ongoing
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Recall: Z-2404-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2404-2026
- Event ID
- 98941
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Neuromodulation Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- June 17, 2026
- Initiation Date
- April 29, 2026
- Classification Date
- June 11, 2026
- Address
- 25155 Rye Canyon Loop, N/A, Valencia, CA, 91355-5004, United States
Description
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Reason
Sterile anchors my lack sterility assurance.
Code Info
GTIN: 08714729905318/Lot # 35107836
Distribution
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Quantity
43 units