FDA-Device2026-10-16Class II
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Hazard
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.
Sold states
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,
Affected count
3746 units
Manufactured in
200 Medtronic Dr, Lafayette, Colorado, United States
Products
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2027More Medtronic Navigation, Inc. recalls
- FDA-Device2026-10-16Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
- FDA-Device2026-10-16Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- FDA-Device2026-10-16Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.