FDA Medical devices recall ·
Magseed Pro 7 cm soft tissue marker recall
- Recall number
- Z-0316-2026
- Date
- (initiated October 1, 2025)
- Company / brand
- Endomagnetics Ltd
St. Johns Innovation Park, Cambridge, N/A, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,760 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for contamination with cotton fibers.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Indiana Kentucky Maryland Maine Michigan Minnesota Missouri North Carolina North Dakota Nebraska New Hampshire New Jersey New York Ohio Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0316-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.