Medtronic Navigation, Inc.: Neurological Stereotaxic Instrument
Recall Summary Medtronic is recalling Biopsy Needle Kits used with neurosurgical navigation systems because the reflective material on tracking spheres varies and may prevent the navigation system from properly detecting and following the surgical instruments. The kits were distributed across the United States, Puerto Rico, and several international locations. This is a Class II recall affecting medical devices used in hospitals and surgical centers.
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, 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/74e5070c-ee44-4768-af43-d1c06bcbc84d