Recalls → Z-0194-2027
Class II Recall · Z-0194-2027
Report Date: 2026-10-28 · Status: Ongoing
Medtronic Navigation, Inc. — Medical Devices Recall
Product Description: Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Reason for Recall: 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.
Distribution Pattern: 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