← FDA ENFORCEMENT
Z-0317-2026Class II

ENDOMAGNETICS LTD

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
ENDOMAGNETICS LTD
Product type
Device
Status
Ongoing
Report date
2025-11-05
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.
Firm state
N/A
Product quantity
540 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Potential for contamination with cotton fibers.

Product 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.

Code / lot info

Model No. MS2-17-1-12. GTIN:15060391210466. UDI: 15060391210466250327-01, 15060391210466250415-07, 15060391210466250523-10, 15060391210466250612-50. Batch Number: 250327-01, 250415-07, 250523-10, 250612-50.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →