BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-0316-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0316-2026
    Event ID
    97680
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ENDOMAGNETICS LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2025
    Initiation Date
    October 1, 2025
    Classification Date
    October 24, 2025
    Address
    St. Johns Innovation Park, Cowley Road, Cambridge, N/A, N/A, United Kingdom

    Description

    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.

    Reason

    Potential for contamination with cotton fibers.

    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.

    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

    1,760 units