RecallDepth

Magseed 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.

This recall is currently active, issued October 24, 2025. It was issued by Endomagnetics Ltd St. Johns Innovation Park Cowley Road Cambridge United Kingdom.

Company
Endomagnetics Ltd St. Johns Innovation Park Cowley Road Cambridge United Kingdom
Recall Initiated
October 1, 2025
Posted
October 24, 2025
Recall Number
Z-0316-2026
Quantity
1,760 units
Official Source
View on FDA website ↗

Reason for Recall

Potential for contamination with cotton fibers.

Distribution

Worldwide - 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.

Lot / Code Info

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.

Root Cause

Process control

Action Taken

Endomagnetics, 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.

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