Recall Z-0317-2026— ENDOMAGNETICS LTD
Class II · Ongoing
Class II FDA medical device recall by ENDOMAGNETICS LTD, initiated 2025-10-01. It names one FDA 510(k) clearance: K232865. 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..
- Recalling firm
- ENDOMAGNETICS LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-01
- Firm location
- Cambridge, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Potential for contamination with cotton fibers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.