Merit Medical Embosphere Microspheres
Embosphere syringes may have holes in packaging that could affect the sterile barrier and lead to infection.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Merit Medical Systems, Inc. recalled Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam and other Embosphere syringes because 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. The recall began August 10, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF
- UDI-DI
- 00884450116715
- 00884450109519
- 00884450364154
- 00884450403136
- Affected units
- 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,
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Georgia and the countries of France, Ireland, Canada, Switzerland.
- Event ID
- 99541
- Recall No.
- Z-3305-2026
- Company
- Merit Medical Systems, Inc.South Jordan, Utah
- Hazard
- Sterility failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
