Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Ma
FDA device recall Z-0316-2026 · posted 2025-10-24 · Open, Classified
Recall details
- Recalling firm
- ENDOMAGNETICS LTD
- Reason for recall
- Potential for contamination with cotton fibers.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NEU
- Quantity affected
- 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.
- Date initiated
- 2025-10-01
- Date posted
- 2025-10-24
- Location
- Cambridge, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Magseed Pro Magnetic Marker System (K232865) | Endomagnetics Ltd., | 2024-06-28 |