Z-3305-2026

Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900...

Name: Z-3305-2026 Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900...
Creator: Merit Medical Systems, Inc.
Published: 2026-08-10
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2026-08-10 / Open, Classified

FDA source

Recall record

Recall number: Z-3305-2026
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-09-25
Recalling firm: 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
Product code: KRD Device, Vascular, For Promoting Embolization
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.
FDA root cause: Process control
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.
Quantity in commerce: 104
Distribution: Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
Product codes and lots: 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 code KRD

K181300Class IIEmbosphere MicrospheresBiosphere Medical, S.A. / cleared 2018-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)