RecallRadar

FDA Device recall Z-0317-2026

Magseed Pro 12 cm soft tissue marker

On 2025-11-05 the FDA classified a Class II recall of Magseed Pro 12 cm soft tissue marker by Endomagnetics, citing potential for contamination with cotton fibers.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0317-2026
ClassificationClass II
Statusongoing
Initiated2025-10-01
Published2025-11-05
Last updated2026-09-13 11:57 UTC
CompanyEndomagnetics
DistributionUS

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 use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Reason

Potential for contamination with cotton fibers.

Identifiers

code_info
Model No. MS2-17-1-12. GTIN:15060391210466. UDI: 15060391210466250327-01, 15060391210466250415-07, 15060391210466250523…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0317-2026%22

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