Embosphere recallZ-3305-2026 · Merit Medical Systems, Inc. · initiated Aug 10, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3305-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2026
- Posted by the FDA
- Sep 25, 2026
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 104
- Product code
- KRD
- FDA submissions
- K181300
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
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
Code information (models, lots, serial numbers)
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.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Embosphere® 00884450116715Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall8 reports
- Embosphere® 00884450403136Biosphere Medical · Device, Vascular, for Promoting Embolization1 recall1 report
- Embosphere® 00884450109519Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall0 reports
Product lines
Other devices under the same FDA submission
8 devices cleared under K181300 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Embosphere® 00884450402948Biosphere Medical · Device, Vascular, for Promoting Embolization1 death32 reports
- Embosphere® 00884450403440Biosphere Medical · Device, Vascular, for Promoting Embolization1 death13 reports
- Embosphere® 00884450403464Biosphere Medical · Device, Vascular, for Promoting Embolization1 death6 reports
- Embosphere® 00884450403204Biosphere Medical · Device, Vascular, for Promoting Embolization5 reports
- Embosphere® 00884450403426Biosphere Medical · Device, Vascular, for Promoting Embolization4 reports
- Embosphere® 00884450403174Biosphere Medical · Device, Vascular, for Promoting Embolization3 reports
- Embosphere® 00884450403150Biosphere Medical · Device, Vascular, for Promoting Embolization1 report
- Embosphere® 00884450403402Biosphere Medical · Device, Vascular, for Promoting Embolization1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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