FDA recall Z-2404-2026
Boston Scientific Neuromodulation Corporation · Class II · device
Product
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Reason for recall
Sterile anchors my lack sterility assurance.
Distribution
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-04-29
- Report date
- 2026-06-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Valencia, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2404-2026