# Class II recall Z-0195-2027: Medtronic Navigation, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0195-2027 |
| Recalling firm | Medtronic Navigation, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Medtronic NDI Passive Spheres  REF: 8801074, Sterile EO, 4/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 | 83,594 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 |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0195-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.