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RecallWatchMedical Device Safety
Class IIOngoingZ-2404-2026

Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318

Boston Scientific Neuromodulation CorporationValencia, CA, United StatesReported Jun 17, 2026 · 1 month ago
Legal News Analyst ·

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:M365SC43180
    GTIN 08714729905318/Lot
    Affected lot
    35107836

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 details

US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

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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