FDA-Device2026-10-07Class IIPACKAGING DEFECT
Merit Medical Embosphere microspheres recalled for compromised sterile packaging
What this means
Merit Medical Systems is recalling Embosphere microspheres used in tumor and blood vessel procedures. Some units have holes in their packaging that could compromise the sterile barrier, potentially exposing the product to contamination and increasing infection risk if used.
- If your facility has received affected Embosphere products (REF: S420GH/EUA, S620GH/EUA, S820GH/CAB, S1020GH/C, or S1020GH/EUA), stop using them immediately.
- Contact Merit Medical Systems for instructions on returning or disposing of affected units.
- Check packaging for visible holes or damage before use.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
Affected count
104
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3305-2026Want us to check the next one for you?
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