FDA Recall Open, Classified

Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. 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.

Recall: Z-0317-2026 · Initiated October 1, 2025

Recall

Recall Number
Z-0317-2026
Event Number
97680
Firm
ENDOMAGNETICS LTD St. Johns Innovation Park Cowley Road Cambridge United Kingdom
FEI Number
3012644426
Product Code
NEU
Status
Open, Classified
Root Cause
Process control
Initiated
October 1, 2025
Posted
October 24, 2025

Description

Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. 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.

Reason

Potential for contamination with cotton fibers.

Action

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.

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.

Quantity

540 units