Device recall

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

FDA recall source

Recall number

Z-0195-2027

Event id

99895

Status

Ongoing

FDA classification

Class II

Recalling firm

Medtronic Navigation, Inc.

Report date

Oct 28, 2026

Posted

Oct 16, 2026

Initiated

Aug 31, 2026

Center classification date

Oct 16, 2026

Product code

HAW

Device type

Neurological Stereotaxic Instrument

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.

Root cause

Under Investigation by firm

Quantity

83,594 units

Code info

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

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,

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K033621

Location

Lafayette, CO, United States