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Class II recall Z-0195-2027: Medtronic Navigation, Inc. vs Class II recall Z-0196-2027: Medtronic Navigation, Inc.: FDAPulse comparison
Class II recall Z-0195-2027: Medtronic Navigation, Inc. (2026-10-28) and Class II recall Z-0196-2027: Medtronic Navigation, Inc. (2026-10-28) are peer FDAPulse records in Colorado.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Class II recall Z-0195-2027: Medtronic Navigation, Inc. compare to Class II recall Z-0196-2027: Medtronic Navigation, Inc.?
| Field | Class II recall Z-0195-2027: Medtronic Navigation, Inc. | Class II recall Z-0196-2027: Medtronic Navigation, Inc. |
|---|---|---|
| Record | Device recall | Device recall |
| Recall number | Z-0195-2027 | Z-0196-2027 |
| Recalling firm | Medtronic Navigation, Inc. | Medtronic Navigation, Inc. |
| Classification | Class II | Class II |
| Status | Ongoing | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated | Voluntary: Firm initiated |
| Specialty | Other | Other |
| Product | Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly | Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly |
| 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. | 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. |
| Quantity | 83,594 units | 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, | 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, |
| Recall initiated | 2026-08-31 | 2026-08-31 |
| Reported | 2026-10-28 | 2026-10-28 |
| Firm location | Lafayette, CO, United States | Lafayette, CO, United States |
| Predicate Speed & CAPA Advisory Opportunity Score | 68/100 | 68/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Class II recall Z-0195-2027: Medtronic Navigation, Inc. · Class II recall Z-0196-2027: Medtronic Navigation, Inc.
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