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Recall Observatory FDA recall evidence

Device product

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.

Z-0316-2026

October 01, 2025

Class II

Product summary

Firm
ENDOMAGNETICS LTD
Event
Event 97680
Status
Ongoing
Classification
Class II
Quantity
1,760 units
Official record key
device-enforcement:Z-0316-2026

Official wording

Reason: Potential for contamination with cotton fibers.

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for contamination with cotton fibers.