Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 200 Medtronic Dr · Lafayette, CO · 80026-3735
Is this the product you have?
- Medtronic Biopsy Needle Kit
- REF9733068, Passive, Sterile EO, Rxonly
- Lot codes and dates
- UDI00643169702943/
- Lots066500526 066501226 066503326 066504726 066506326 066509826
- UDI00643169030121/Lots: 066500526 066506326
- Amount recalled
- 3746 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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