Z-0316-2026Class II

Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro...

Name: Z-0316-2026 Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro...
Creator: Endomagnetics Ltd
Published: 2025-10-01
License: https://open.fda.gov/license/

Endomagnetics Ltd / initiated 2025-10-01 / Open, Classified / root cause: manufacturing process

FDA source

ENDOMAGNETICS LTD began a recall of Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use... on 2025-10-01. FDA classified it as Class II and gives the reason as "Potential for contamination with cotton fibers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0316-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-01
Posted: 2025-10-24
Recalling firm: Endomagnetics Ltd
Product: Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. 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.
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: Potential for contamination with cotton fibers.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Endomagnetics, Ltd notified consignees on about 10/01/2025 via certified mail and email through 3rd party IQVIA. Consignees were instructed to examine their inventory and cease use of those units, quarantine any affected units, complete and return the response form, forward the notification to all affected personnel and customers if further distributed, and post a copy of the notice in a visible area for awareness and keep a copy for your records.
Quantity in commerce: 1,760 units
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.
Product codes and lots: Model Number. MS2-17-1-07. GTIN:15060391210459. UDI: 15060391210459241227-01;15060391210459250212-02; 15060391210459250324-03; 15060391210459250415-06; 15060391210459250523-11; 15060391210459250612-51 Batch Numbers: 250212-02, 250324-03, 250415-06, 250523-11, 241227-01, 250612-51.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0316-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0316-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0317-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24

Product code NEU

K232865Class IIMagseed Pro Magnetic Marker SystemEndomagnetics Ltd., / cleared 2024-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)