ENDOMAGNETICS LTD recalls Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description:…

Potential for contamination with cotton fibers.

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0316-2026
• FDA 510(k) clearance · K232865The device's official FDA premarket clearance record
• FDA device classification · NEUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ENDOMAGNETICS LTDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.