Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., 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 NDI Passive Spheres REF8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- Lot codes and dates
- UDI00643169278028/
- Lots
25032912503331250338125040112504021250415125043612505101250511125052312505291250541125054912505661250610125061812506401250643125064912506501250955125095612509831251001125100312510171251018125102212510241251056125106112510771251078125112612511521251162125116312512091
- UDI20805832070030/
- Lots
170 of 170 codes
250243125120912502431250246125025112502531250254125030712503081250309125031012503111250312125031612503171250318125031912503201250321125032212503251250326125032712503281250329125033312503341250335125033612503381250340125040112504021250404125040512504071250410125041512504201250428125043412504351250436125043712505101250511125051212505141250516125052312505241250525125052612505281250529125053012505311250536125054012505411
- Amount recalled
- 476,256 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.
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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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