Medtronic Navigation, Inc. recalls Medtronic NDI Passive Spheres REF: 8801071
- Recalling company
- Medtronic Navigation, Inc.
- Product
- Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/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 – may cause temporary or medically reversible health consequences
- Recall date
- Aug 31, 2026
- Reported
- Oct 28, 2026
- 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,
- Status
- Ongoing
- Quantity
- 14210 units
- Lot / codes
- UDI: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091
- Company location
- Lafayette, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0194-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0194-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.