FDAPulse / compare
Class II recall Z-0194-2027: Medtronic Navigation, Inc. vs Class II recall Z-0196-2027: Medtronic Navigation, Inc.: FDAPulse comparison
Class II recall Z-0194-2027: 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-0194-2027: Medtronic Navigation, Inc. compare to Class II recall Z-0196-2027: Medtronic Navigation, Inc.?
| Field | Class II recall Z-0194-2027: Medtronic Navigation, Inc. | Class II recall Z-0196-2027: Medtronic Navigation, Inc. |
|---|---|---|
| Record | Device recall | Device recall |
| Recall number | Z-0194-2027 | 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: 8801071, Sterile EO, 1/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 | 14210 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-0194-2027: Medtronic Navigation, Inc. · Class II recall Z-0196-2027: Medtronic Navigation, Inc.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.