The Recall Desk
HighFDA (Devices)·Z-0317-2026·Announced 2025-11-05

Magseed Pro 12 cm markers recalled over potential cotton fiber contamination

Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: foreign fiber contamination on a device placed in soft tissue is a hazard, and no injuries are reported.

Plain-English summary

The Magseed Pro 12 cm soft tissue marker, model MS2-17-1-12, is being recalled. The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device consisting of a marker preloaded in a 17 gauge needle delivery system.

The recall concerns the potential for contamination with cotton fibers.

The recall covers 540 units carrying GTIN 15060391210466, distributed worldwide including in California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Iowa, Idaho, Indiana, Kentucky, Maryland, Maine, Michigan and Minnesota. The FDA has classified the action as Class II.

The enforcement record describes the contamination risk and reports no injuries. Because the marker is placed in soft tissue, facilities should quarantine affected stock and follow the firm's instructions.

The recalled product

Product
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
Manufacturer
ENDOMAGNETICS LTD
Category
Medical Device — Tissue marker
Hazard
Affected units
540

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ENDOMAGNETICS LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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