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Class IIOngoing

Medtronic Navigation, Inc. recalls 4 products

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Medtronic Navigation, Inc.
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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,
Where
Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99895…

Products (4)

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

    Codes/lots: UDI: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091Quantity: 14210 unitsRecall no. Z-0194-2027Class II

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

    Codes/lots: 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 2511601Quantity: 83,594 unitsRecall no. Z-0195-2027Class II

  3. Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly

    Codes/lots: 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 2Quantity: 476,256 unitsRecall no. Z-0196-2027Class II

  4. Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly

    Codes/lots: UDI: 00643169702943/ Lots: 066500526 066501226 066503326 066504726 066506326 066509826; UDI:00643169030121/Lots: 066500526 066506326Quantity: 3746 unitsRecall no. Z-0197-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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