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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- ENDOMAGNETICS LTD
- Category
- Medical Device — Tissue marker
- 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
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 →Related recalls
Same manufacturer · ENDOMAGNETICS LTD
See all →- HighSoft tissue markers recalled over potential contamination with cotton fibers
FDA (Devices) · 2025-11-05
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