Z-0316-2026 Class II Ongoing
FDA device recall Z-0316-2026 was initiated by ENDOMAGNETICS LTD on October 1, 2025 and is designated Class II. Reason for recall: Potential for contamination with cotton fibers. The recall status is ongoing. Affected quantity: 1,760 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- October 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,760 units
Product 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 for Recall
Potential for contamination with cotton fibers.
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.
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.