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U.S. Department of Health and Human Services

Class 2 Device Recall Magseed Pro

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 Class 2 Device Recall Magseed Prosee related information
Date Initiated by FirmOctober 01, 2025
Date PostedOctober 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0316-2026
Recall Event ID 97680
510(K)NumberK232865 
Product Classification Marker, radiographic, implantable - Product Code NEU
ProductMagseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Code Information Model Number. MS2-17-1-07. GTIN:15060391210459. UDI: 15060391210459241227-01;15060391210459250212-02; 15060391210459250324-03; 15060391210459250415-06; 15060391210459250523-11; 15060391210459250612-51 Batch Numbers: 250212-02, 250324-03, 250415-06, 250523-11, 241227-01, 250612-51.
FEI Number 3012644426
Recalling Firm/
Manufacturer		 ENDOMAGNETICS LTD
St. Johns Innovation Park
Cowley Road
Cambridge United Kingdom
Manufacturer Reason
for Recall		Potential for contamination with cotton fibers.
FDA Determined
Cause 2		Process control
ActionEndomagnetics, Ltd notified consignees on about 10/01/2025 via certified mail and email through 3rd party IQVIA. Consignees were instructed to examine their inventory and cease use of those units, quarantine any affected units, complete and return the response form, forward the notification to all affected personnel and customers if further distributed, and post a copy of the notice in a visible area for awareness and keep a copy for your records.
Quantity in Commerce1,760 units
DistributionWorldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.
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 = NEU
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