Medtronic Navigation, Inc.: Neurological Stereotaxic Instrument
Recall Summary Medtronic is recalling NDI Passive Spheres (sterile navigation markers) used in neurological surgery because variations in their reflective coating may prevent the surgical navigation system from properly detecting and tracking them during procedures. The product was distributed across the United States, Puerto Rico, and several international locations including China, Taiwan, and Hong Kong.
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- Reason
- Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b8374600-0a8d-4010-a537-a44d64c1f60e