Notice names this product. Boston Scientific Neuromodulation’s Boston Scientific Model SC-4318 is named in FDA Class II recall Z-2404-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Sterile anchors my lack sterility assurance. Identifying details: GTIN: 08714729905318/Lot # 35107836. Units affected: 43 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Boston Scientific Model SC-4318
Company / brand
Boston Scientific Neuromodulation
Lot / serial / date codes
GTIN: 08714729905318/Lot # 35107836
Distribution
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Agency product description and boundaries
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.