Medtronic NDI Passive Spheres REF: 8801074 recall (Medtronic Navigation, Inc.)
Medical deviceClass IIOngoing
Summary: Medtronic Navigation, Inc. is recalling 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.
What is being recalled
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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, (states named: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0195-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 31, 2026 |
| Reported | October 28, 2026 |
| Company | Medtronic Navigation, Inc. |
| Company location | Lafayette, CO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 83,594 units |
More recalls from Medtronic Navigation, Inc. · all medical device recalls · recalls from August 2026