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Z-2404-2026Class II

Boston Scientific Neuromodulation Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Boston Scientific Neuromodulation Corporation
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Firm state
CA
Product quantity
43 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Sterile anchors my lack sterility assurance.

Product description

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

Code / lot info

GTIN: 08714729905318/Lot # 35107836

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →