FDA Medical devices recall ·
Boston Scientific Model SC-4318, Clik X Anchor recall
- Recall number
- Z-2404-2026
- Date
- (initiated April 29, 2026)
- Company / brand
- Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 43 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Why was it recalled?
Sterile anchors my lack sterility assurance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 08714729905318/Lot # 35107836
Distribution
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
States: Florida Louisiana Maryland Oklahoma South Carolina Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2404-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.