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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Endomag Magseed Pro Soft Tissue Markers Recalled for Fiber Contamination

Agency Publication Date: October 24, 2025
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Summary

Endomagnetics Ltd has recalled 2,300 units of the Endomag Magseed Pro Magnetic Marker System, specifically the 7 cm and 12 cm soft tissue marker models. These sterile, single-use devices are used by surgeons to mark tissue for radiographic tracking, but they may be contaminated with cotton fibers. Healthcare providers and hospitals should stop using the affected markers immediately and contact the manufacturer to arrange for their return or replacement.

Risk

The presence of cotton fibers in a sterile surgical device can cause an inflammatory immune response or infection at the site where the marker is placed. This could potentially require additional medical treatment or surgical intervention to address the foreign material contamination.

What You Should Do

  1. This recall affects Endomag Magseed Pro Magnetic Marker Systems, which include a soft tissue marker preloaded in a 17-gauge needle delivery system.
  2. To identify affected products, check the packaging for model numbers MS2-17-1-07 (7 cm marker) or MS2-17-1-12 (12 cm marker). For these models, verify the batch numbers and Unique Device Identifier (UDI) codes on the label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Endomagnetics Ltd or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Magseed Pro 7 cm soft tissue marker
Model / REF:
MS2-17-1-07
Lot Numbers:
250212-02
250324-03
250415-06
250523-11
241227-01
250612-51
UDI:
15060391210459241227-01
15060391210459250212-02
15060391210459250324-03
15060391210459250415-06
15060391210459250523-11
15060391210459250612-51
GTIN:
15060391210459

The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System.

Product: Magseed Pro 12 cm soft tissue marker
Model / REF:
MS2-17-1-12
Lot Numbers:
250327-01
250415-07
250523-10
250612-50
UDI:
15060391210466250327-01
15060391210466250415-07
15060391210466250523-10
15060391210466250612-50
GTIN:
15060391210466

The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97680
Status: Active
Manufacturer: ENDOMAGNETICS LTD
Sold By: Authorized medical distributors; Hospitals; Surgical centers
Manufactured In: United Kingdom
Units Affected: 2 products (1,760 units; 540 units)
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.