Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam
- Recalling company
- Merit Medical Systems, Inc.
- Product
- Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 10, 2026
- Reported
- Oct 7, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
- Status
- Ongoing
- Quantity
- 104
- Lot / codes
- 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,
- Company location
- South Jordan, UT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3305-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3305-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.