- Recalling firm
- Medtronic Navigation, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI: 00643169702943/ Lots: 066500526 066501226 066503326 066504726 066506326 066509826; UDI:00643169030121/Lots: 066500526 066506326
- Units affected
- 3746 units
- 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 Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,
- Firm location
- Lafayette, CO, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0197-2027
- Recall initiated
- August 31, 2026
- FDA classification date
- October 16, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99895
- Last updated on HTM Vibe
- November 3, 2026
