Recall Z-3305-2026— Merit Medical Systems, Inc.

Name: FDA recall Z-3305-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-10

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2026-08-10. It names one FDA 510(k) clearance: K181300. 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: 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..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-10
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K181300 — Embosphere MicrospheresBiosphere Medical, S.A.·cleared 2018-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.