Is Medtronic Navigation, Inc. recalled?

Yes — a recall has been published. 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.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly

Check the device or its packaging for

UDI: 20805832070023/ Lot codes: 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

Why: 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.
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,
Company: Medtronic Navigation, Inc.
Announced: 28 October 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 31 August 2026

Source: FDA record Z-0195-2027 · retrieved 16 October 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.