Medtronic Biopsy Needle Kit recall (Medtronic Navigation, Inc.)
Medical deviceClass IIOngoing
Summary: Medtronic Navigation, Inc. is recalling Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, 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 Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, 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: 00643169702943/ Lots: 066500526 066501226 066503326 066504726 066506326 066509826; UDI:00643169030121/Lots: 066500526 066506326
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-0197-2027 |
| 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 | 3746 units |
More recalls from Medtronic Navigation, Inc. · all medical device recalls · recalls from August 2026