Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam

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.

On 8/10/2026, recall notices were mailed and emailed to customers who were asked to do the following: 1) Discontinue use and return affected devices to firm. 2) Ensure that applicable personnel within your organization are made aware of this recall. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4) Complete and return the response form via email to RESPONSE@merit.com If you have any questions concerning this communication, please contact the firm's Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748. Canadian customers can contact the firm at at Canada@merit.com or by phone at +1 800 364 4370.

• FDA enforcement recordOfficial FDA database entry for Z-3305-2026
• FDA 510(k) clearance · K181300The device's official FDA premarket clearance record
• FDA device classification · KRDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.3300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Merit Medical Systems, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.