Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318
Reason for recall
Sterile anchors my lack sterility assurance.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Boston Scientific Model SC-4318, Clik X Anchor REF:M365SC43180GTIN 08714729905318/LotAffected lot35107836
What the firm is doing
On April 29, 2026, Boston Scientific issued a Urgent Medical Device Recall via mail. Boston Scientific ask consignees to take the following actions: 1. Do NOT use Affected Product (Table 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific. 2 Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions. 5. Return Affected Product.
DistributionShow detailsHide
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2404-2026
- FDA device classification · LGWOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific Neuromodulation CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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