Medtronic Navigation, Inc. recalls Medtronic Biopsy Needle Kit
- Recalling company
- Medtronic Navigation, Inc.
- Product
- 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.
- 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
- 3746 units
- Lot / codes
- UDI: 00643169702943/ Lots: 066500526 066501226 066503326 066504726 066506326 066509826; UDI:00643169030121/Lots: 066500526 066506326
- Company location
- Lafayette, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0197-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0197-2027 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.