FDA recall, , Moderate risk
Medtronic NDI Passive Spheres and Biopsy Needle Kit
Medtronic NDI Passive Spheres and Biopsy Needle Kit have variation in reflective material that may affect navigation tracking.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Navigation, Inc. recalled Medtronic NDI Passive Spheres and Medtronic Biopsy Needle Kit because variation in the reflective material may affect the ability of the navigation system to detect and track the spheres. The company began the recall on August 31, 2026, and the FDA added it to the Enforcement Report on October 16, 2026.
Distribution included US states and territories such as Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and District of Columbia, and OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China, Taiwan, Hong Kong.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
4 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
- UDI-DI
- 00643169702943
- 00643169030121
- Lot code
- 066500526
- 066501226
- 066503326
- 066504726
- 066506326
- 066509826
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- UDI-DI
- 00643169278028
- 20805832070030
- Lot code
- 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
- 2502431
- 2502461
- 2502511
- 2502531
- 2502541
- 2503071
- 2503081
- 2503091
- 2503101
- 2503111
- 2503121
- 2503161
- 2503171
- 2503181
- 2503191
- 2503201
- 2503211
- 2503221
- 2503251
- 2503261
- 2503271
- 2503281
- 2503341
- 2503351
- 2503361
- 2503401
- 2504041
- 2504051
- 2504071
- 2504101
- 2504201
- 2504281
- 2504341
- 2504351
- 2504371
- 2505121
- 2505141
- 2505161
- 2505241
- 2505251
- 2505261
- 2505281
- 2505301
- 2505311
- 2505361
- 2505401
- 2505501
- 2505511
- 2505601
- 2505621
- 2505631
- 2506091
- 2506111
- 2506121
- 2506141
- 2506151
- 2506171
- 2506191
- 2506201
- 2506211
- 2506261
- 2506271
- 2506281
- 2506351
- 2506361
- 2506381
- 2506421
- 2506461
- 2506471
- 2506481
- 2506521
- 2506531
- 2506591
- 2506641
- 2507081
- 2507091
- 2509421
- 2509431
- 2509531
- 2509581
- 2509591
- 2509601
- 2509611
- 2509731
- 2509741
- 2509751
- 2509761
- 2509771
- 2509821
- 2509841
- 2510021
- 2510041
- 2510051
- 2510061
- 2510071
- 2510081
- 2510091
- 2510101
- 2510131
- 2510141
- 2510151
- 2510191
- 2510231
- 2510291
- 2510531
- 2510541
- 2510571
- 2510761
- 2510791
- 2510801
- 2510811
- 2511061
- 2511071
- 2511081
- 2511131
- 2511141
- 2511171
- 2511181
- 2511191
- 2511201
- 2511211
- 2511251
- 2511271
- 2511281
- 2511301
- 2511311
- 2511321
- 2511511
- 2511531
- 2510351
- 2510381
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
- UDI-DI
- 20805832070016
- Lot code
- 2506331
- 2506571
- 2510111
- 2510511
- 2511091
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
- UDI-DI
- 20805832070023
- Lot code
- 2503141
- 2503241
- 2503411
- 2503491
- 2504081
- 2504091
- 2504211
- 2504301
- 2504331
- 2505211
- 2505221
- 2505351
- 2505641
- 2505651
- 2505681
- 2506081
- 2506161
- 2506341
- 2506551
- 2506581
- 2509781
- 2509791
- 2509811
- 2510121
- 2510741
- 2510751
- 2511101
- 2511121
- 2511501
- 2511601
Recall details
- Company began the recall
- Sold in
- 50 states and DC
US: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia HI Iowa ID Illinois IN Kansas Kentucky Kentucky Louisiana Massachusetts MD ME Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio OK OR Pennsylvania PR Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,
- Company
- Medtronic Navigation, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99895
- Recall numbers
- Z-0194-2027 to Z-0197-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
