Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magneti
Summary
The FDA issued a Class II for Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Desc by ENDOMAGNETICS LTD. Reason: Potential for contamination with cotton fibers..
Details
Source
Device Recall
External ID
Z-0317-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 540 units
Reason for Recall
Potential for contamination with cotton fibers.
Distribution
Worldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-01
Company
Cambridge, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ENDOMAGNETICS LTD has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ENDOMAGNETICS LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ENDOMAGNETICS LTD have FDA actions?
ENDOMAGNETICS LTD has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0317-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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