Merit Medical Systems, Inc.: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Steri
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
- Recall initiated
- 2026-08-10
- Code info
- 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,
- Product quantity
- 104
- Voluntary mandated
- Voluntary: Firm initiated
- City
- South Jordan
- State
- UT
- Country
- United States
- Event id
- 99541
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