Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
S420GH/EUA | Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, , S620GH/EUA |
S820GH/CAB | Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam |
S1020GH/C | Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, , S1020GH/EUA |
- Lot codes and dates
S420GH/EUA/00884450116715/X3467294-1S620GH/EUA/00884450109519/X3472987-1S820GH/CAB/00884450364154/X3472923-AS1020GH/C/00884450403136/X3482321-5S1020GH/EUA/00884450109519/X3482321-1
- Amount recalled
- 104
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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