Class 2 Device Recall Medtronic NDI Passive Spheres

• Date Initiated by Firm: August 31, 2026
• Date Posted: October 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0196-2027
• Recall Event ID: 99895
• 510(K)Number: K033621
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
• Code Information: UDI: 00643169278028/ Lots: 2503291 2503331 2503381 2504011 2504021 2504151 2504361 2505101 2505111 2505231 2505291 2505411 2505491 2505661 2506101 2506181 2506401 2506431 2506491 2506501 2509551 2509561 2509831 2510011 2510031 2510171 2510181 2510221 2510241 2510561 2510611 2510771 2510781 2511261 2511521 2511621 2511631 2512091; UDI: 20805832070030/ Lots: 2502431 2512091 2502431 2502461 2502511 2502531 2502541 2503071 2503081 2503091 2503101 2503111 2503121 2503161 2503171 2503181 2503191 2503201 2503211 2503221 2503251 2503261 2503271 2503281 2503291 2503331 2503341 2503351 2503361 2503381 2503401 2504011 2504021 2504041 2504051 2504071 2504101 2504151 2504201 2504281 2504341 2504351 2504361 2504371 2505101 2505111 2505121 2505141 2505161 2505231 2505241 2505251 2505261 2505281 2505291 2505301 2505311 2505361 2505401 2505411 2505491 2505501 2505511 2505601 2505621 2505631 2505661 2506091 2506101 2506111 2506121 2506141 2506151 2506171 2506181 2506191 2506201 2506211 2506261 2506271 2506281 2506351 2506361 2506381 2506401 2506421 2506431 2506461 2506471 2506481 2506491 2506501 2506521 2506531 2506591 2506641 2507081 2507091 2509421 2509431 2509531 2509551 2509561 2509581 2509591 2509601 2509611 2509731 2509741 2509751 2509761 2509771 2509821 2509831 2509841 2510011 2510021 2510031 2510041 2510051 2510061 2510071 2510081 2510091 2510101 2510131 2510141 2510151 2510171 2510181 2510191 2510221 2510231 2510241 2510291 2510531 2510541 2510561 2510571 2510611 2510761 2510771 2510781 2510791 2510801 2510811 2511061 2511071 2511081 2511131 2511141 2511171 2511181 2511191 2511201 2511211 2511251 2511261 2511271 2511281 2511301 2511311 2511321 2511511 2511521 2511531 2511631 2512091 2510351 2510381
• FEI Number: 1000517638
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 200 Medtronic Dr; Lafayette CO 80026-3735
• For Additional Information Contact: Medtronic Technical ; 720-890-3200
• Manufacturer 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 Determined 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 neuro.quality@medtronic.com.; 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: spheres-na@ndigital.com
• Quantity in Commerce: 476,256 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HAW