Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Embosphere Microspheres

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Embosphere Microspheressee related information
Date Initiated by FirmAugust 10, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3305-2026
Recall Event ID 99541
510(K)NumberK181300 
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
ProductEmbosphere 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 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.
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer 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 Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce104
DistributionWorldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KRD
-
-