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Open, Classified

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

FDA Recall Z-3305-2026 · Posted 2026-09-25

Recall StatusOpen, Classified
Product CodeKRD
Date Initiated2026-08-10
Product Quantity104

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.

Firm Action

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 [email protected] If you have any questions concerning this communication, please contact the firm's Customer Service via email at [email protected] or via phone at +1 800 356 3748. Canadian customers can contact the firm at at [email protected] or by phone at +1 800 364 4370.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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