CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Medtronic NDI Passive Spheres recalled by Medtronic Navigation
Medtronic Navigation is recalling Medtronic NDI Passive Spheres, distributed in 44 states. The recall was initiated on 31 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0194-2027
- FDA event ID
- 99895
- Recalling firm
- Medtronic Navigation, Lafayette, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2026
- FDA classified
- 16 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2026 | Recall initiated by company | |
| 16 Oct 2026 | Classified by FDA | +46 days |
| 28 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Where it was distributed
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,
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091
Where was it sold?
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,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99895This product is part of a recall event; the main page for the event is Medtronic Biopsy Needle Kit recalled by Medtronic Navigation.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic Biopsy Needle Kit recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states | |
| CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states | |
| CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
More recalls from Medtronic Navigation
All 96| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic NDI Passive Spheres recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic Biopsy Needle Kit recalled by Medtronic Navigation | Medtronic Navigation | Sterility | 44 states |
| Device | CLASS II | Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation | Medtronic Navigation | Other | Nationwide |
| Device | CLASS II | StealthStation S8 App versions 1.3.0 and 1.3.2 recalled | Medtronic Navigation | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |