Medtronic Navigation, Inc.: Neurological Stereotaxic Instrument
Recall Summary Medtronic is recalling sterile passive spheres (model 8801074) used with neurological navigation systems because variations in their reflective material may prevent the navigation system from properly detecting and tracking them during procedures. The affected product was distributed across the US, Puerto Rico, and several international locations including China, Taiwan, Hong Kong, and parts of Europe.
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/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/f3b8442f-5f5a-451b-86fb-4576e6e68dc9