Recall Z-0194-2027— Medtronic Navigation, Inc.

Name: FDA recall Z-0194-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-31

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2026-08-31. It names one FDA 510(k) clearance: K033621. Product: Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly. Reason: 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..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-31
Firm location: Lafayette, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K033621 — NDI PASSIVE SPHERESNorthern Digital, Inc.·cleared 2004-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.