FDA recall, , Moderate risk
Boston Scientific Clik X Anchor
The Clik X Anchor may lack sterility assurance.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Neuromodulation Corporation, of Valencia, California, recalled 43 units of its Boston Scientific Model SC-4318, Clik X Anchor REF M365SC43180 because the sterile anchors may lack sterility assurance. The recall began on April 29, 2026, and was added to the FDA's Enforcement Report on June 11, 2026, with distribution in Maryland, Utah, Florida, Louisiana, South Carolina, and Oklahoma.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- UDI-DI
- 08714729905318
- 35107836
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Maryland, Utah, Florida, Louisiana, South Carolina, Oklahoma.
- Company
- Boston Scientific Neuromodulation CorporationValencia, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98941
- Recall number
- Z-2404-2026
- Quantity recalled
- 43 units
All recalls from Boston Scientific Neuromodulation Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
