Recall Z-0317-2026 ยท NEU Marker, Radiographic, Implantable
ENDOMAGNETICS LTD
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.
| Date | Oct 24, 2025 (initiated Oct 1, 2025) |
| Status | Open, Classified |
| Reason | Potential for contamination with cotton fibers. |
| Root cause | Process control |
| 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. |
| Quantity | 540 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232865 | Magseed Pro Magnetic Marker System Endomagnetics Ltd.,, Jun 28, 2024 |