Z-0194-2027

Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly

Name: Z-0194-2027 Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Creator: Medtronic Navigation, Inc.
Published: 2026-08-31
License: https://open.fda.gov/license/

Medtronic Navigation, Inc. / initiated 2026-08-31 / Open, Classified

FDA source

Recall record

Recall number: Z-0194-2027
Status: Open, Classified
Initiated: 2026-08-31
Posted: 2026-10-16
Recalling firm: Medtronic Navigation, Inc.
Product: Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Product code: HAW Neurological Stereotaxic Instrument
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.
FDA root cause: Under Investigation by firm
Action: On September 11, 2026 Medtronic Navigation Inc. issued a Urgent Medical Device Recall notification email. Medtronic ask consignees to take the following actions: 1. Immediately locate and quarantine all unused impacted product(s).; 2. Return unused impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form.; 3. Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information, and email the completed form to Medtronic at [email protected].; 4. If the affected devices have already been utilized and/or discarded, we still ask that you complete and return the Customer Confirmation Form detailing that information.; 5. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.; 6. If you purchase this product directly from NDI, please contact NDI for the list of impacted product and instructions for return: [email protected]
Quantity in commerce: 14210 units
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,
Product codes and lots: UDI: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091

Product code HAW

K033621Class IINdi Passive SpheresNorthern Digital, Inc. / cleared 2004-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)