Class II U.S. Food and Drug Administration

Medtronic NDI Passive Spheres REF: 8801075, Sterile EO recall: Sterile Passive spheres and biopsy needle kits contain variation

Recall published 5 days ago

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.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0196-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Navigation, Inc.
Product type
Medical devices
Units affected
476,256 units
Distribution
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, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming
Made in
United States
Lot / code info
UDI: 00643169278028/ Lots: 2503291 2503331 2503381 2504011 2504021 2504151 2504361 2505101 2505111 2505231 2505291 2505411 2505491 2505661 2506101 2506181 2506401 2506431 2506491 2506501 2509551 2509561 2509831 2510011 2510031 2510171 2510181 2510221 2510241 2510561 2510611 2510771 2510781 2511261 2511521 2511621 2511631 2512091; UDI: 20805832070030/ Lots: 2502431 2512091 2502431 2502461 2502511 2502531 2502541 2503071 2503081 2503091 2503101 2503111 2503121 2503161 2503171 2503181 2503191 2503201 2503211 2503221 2503251 2503261 2503271 2503281 2503291 2503331 2503341 2503351 2503361 2503381 2503401 2504011 2504021 2504041 2504051 2504071 2504101 2504151 2504201 2504281 2504341 2504351 2504361 2504371 2505101 2505111 2505121 2505141 2505161 2505231 2505241 2505251 2505261 2505281 2505291 2505301 2505311 2505361 2505401 2505411 2505491 2505501 2505511 2505601 2505621 2505631 2505661 2506091 2506101 2506111 2506121 2506141 2506151 2506171 2506181 2506191 2506201 2506211 2506261 2506271 2506281 2506351 2506361 2506381 2506401 2506421 2506431 2506461 2506471 2506481 2506491 2506501 2506521 2506531 2506591 2506641 2507081 2507091 2509421 2509431 2509531 2509551 2509561 2509581 2509591 2509601 2509611 2509731 2509741 2509751 2509761 2509771 2509821 2509831 2509841 2510011 2510021 2510031 2510041 2510051 2510061 2510071 2510081 2510091 2510101 2510131 2510141 2510151 2510171 2510181 2510191 2510221 2510231 2510241 2510291 2510531 2510541 2510561 2510571 2510611 2510761 2510771 2510781 2510791 2510801 2510811 2511061 2511071 2511081 2511131 2511141 2511171 2511181 2511191 2511201 2511211 2511251 2511261 2511271 2511281 2511301 2511311 2511321 2511511 2511521 2511531 2511631 2512091 2510351 2510381
UPC codes
00643169278028, 20805832070030

Products covered by this recall

Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00643169278028
  • 20805832070030

Model or item number

On the rating label, the box or the instruction sheet.

  • 8801075
  • 5/Tray 12

Package size

Match the net weight or the piece count on the front of the pack.

  • 12 Pk

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Medtronic Navigation, Inc. — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Medtronic Navigation, Inc. — 200 Medtronic Dr, Lafayette, CO, 80026-3735

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Navigation, Inc. medical devices 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. 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 do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00643169278028, 20805832070030; model number 8801075, 5/Tray 12. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Which states were affected?

The notice lists Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii and others.

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