Boston Scientific Model SC-4318 recall (Boston Scientific Neuromodulation Corporation)
Medical deviceClass IIOngoing
Summary: Boston Scientific Neuromodulation Corporation is recalling Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180. Reason: Sterile anchors my lack sterility assurance.
What is being recalled
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Why
Sterile anchors my lack sterility assurance.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK. (states named: Florida, Louisiana, Maryland, Oklahoma, South Carolina, Utah)
How to tell if yours is affected
GTIN: 08714729905318/Lot # 35107836
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2404-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 29, 2026 |
| Reported | June 17, 2026 |
| Company | Boston Scientific Neuromodulation Corporation |
| Company location | Valencia, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 43 units |
More recalls from Boston Scientific Neuromodulation Corporation · all medical device recalls · recalls from April 2026