FDAClass II · Medical device · Recalled June 17, 2026

Boston Scientific Model SC-4318 recall — Boston Scientific Neuromodulation Corporation

Hazard: Sterile anchors my lack sterility assurance.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2404-2026
Brand: Boston Scientific Neuromodulation
Classification: Class II
Units affected: 43 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Affected products

Boston Scientific Model SC-4318

Companies & origin

Recalling firm location: Valencia, CA, United States
Firm address: 25155 Rye Canyon Loop, N/A, 91355-5004

Identifying details (verbatim from the notice)

Product codes / lots: GTIN: 08714729905318/Lot # 35107836
Distribution: US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Firm notified the public via: N/A
FDA event ID: 98941
Recall initiated: April 29, 2026
FDA classified: June 11, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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