Recall Z-3305-2026 ยท KRD Device, Vascular, For Promoting Embolization
Merit Medical Systems, Inc.
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
| Date | Sep 25, 2026 (initiated Aug 10, 2026) |
| Status | Open, Classified |
| 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. |
| 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 RESPONSE@merit.com If you have any questions concerning this communication, please contact the firm's Customer Service via email at R |
| Quantity | 104 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181300 | Embosphere Microspheres Biosphere Medical, S.A., Jul 16, 2018 |