Class II recall Z-0194-2027: Medtronic Navigation, Inc.
Class II recall Z-0194-2027: Medtronic Navigation, Inc. (Colorado): Medtronic Navigation, Inc. Dated 8 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 8 related CO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0194-2027 |
| Recalling firm | Medtronic Navigation, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/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. |
| Quantity | 14210 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, |
| Recall initiated | 2026-08-31 |
| Reported | 2026-10-28 |
| Firm location | Lafayette, CO, United States |
| Peer records CSV (9 CO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0194-2027: Medtronic Navigation, Inc. and 9 Colorado peers
- Colorado FDAPulse records like this one: 9
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Colorado peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.
What is the FDAPulse record for Class II recall Z-0194-2027: Medtronic Navigation, Inc. in Colorado?
Class II device recall Z-0194-2027 by Medtronic Navigation, Inc.: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the abilit
How does Class II recall Z-0194-2027: Medtronic Navigation, Inc. compare to other Colorado FDAPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most.
Class II recall Z-0194-2027 vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Class II recall Z-0194-2027 | CO | 2026-10-28 | This record |
| Class II recall Z-0197-2027 | CO | 2026-10-28 | View record → |
| Class II recall Z-0196-2027 | CO | 2026-10-28 | Compare Class II recall Z-0194-2027 vs Class II recall Z-0196-2027 → |
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