Device recall
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
- Recall number
- Z-3305-2026
- Event id
- 99541
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 25, 2026
- Product code
- KRD
- Device type
- Device, Vascular, For Promoting Embolization
- 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.
- Root cause
- Process control
- Quantity
- 104
- 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,
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K181300
- Location
- South Jordan, UT, United States