Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Summary
The FDA issued a Class II for Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly by Medtronic Navigation, Inc.. Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to .
Details
Source
Device Recall
External ID
Z-0196-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
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
Quantity Affected: 476,256 units
Reason for Recall
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.
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,
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Lafayette, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Medtronic Navigation, Inc. has 27 FDA actions in our database, including 17 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc. have FDA actions?
Medtronic Navigation, Inc. has 27 FDA actions in our database, including 17 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0196-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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