Medtronic Navigation, Inc. recalls Medtronic NDI Passive Spheres REF: 8801074
- Recalling company
- 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 – 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
- 83,594 units
- Lot / codes
- UDI: 20805832070023/ Lot codes: 2503141 2503241 2503411 2503491 2504081 2504091 2504211 2504301 2504331 2505211 2505221 2505351 2505641 2505651 2505681 2506081 2506161 2506341 2506551 2506581 2509781 2509791 2509811 2510121 2510741 2510751 2511101 2511121 2511501 2511601
- Company location
- Lafayette, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0195-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0195-2027 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.