Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam: recall status
Notice names this product. Merit Medical Systems’s Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam is named in FDA Class II recall Z-3305-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection. Identifying details: S420GH/EUA/00884450116715/X3467294-1, S620GH/EUA/00884450109519/X3472987-1, S820GH/CAB/00884450364154/X3472923-A, S1020GH/C/00884450403136/X3482321-5, S1020GH/EUA/00884450109519/X3482321-1,. Units affected: 104. 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
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam
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.
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, whi…