Medtronic Navigation recalls

Medtronic Navigation has 96 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 28 Oct 2026. 21 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls96since 2012

Last 12 months4reported

Class I77% of total

Ongoing21latest 28 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 1 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 4 0

Severity split

Class I 7 7%Class II 89 93%Class III 0 0%

Why medtronic navigation is recalled

Product types

By year

202644%
202511%
202444%
202355%
202211%
202122%
202055%
201955%
201822%
20171718%

Ongoing medtronic navigation recalls

21 active

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Medtronic NDI Passive Spheres recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
28 Oct 2026Device	CLASS II	Medtronic NDI Passive Spheres recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
28 Oct 2026Device	CLASS II	Medtronic NDI Passive Spheres recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
28 Oct 2026Device	CLASS II	Medtronic Biopsy Needle Kit recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Other	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 1.3.0 and 1.3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide

All medtronic navigation recalls, newest first

96 total

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Medtronic NDI Passive Spheres recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
28 Oct 2026Device	CLASS II	Medtronic NDI Passive Spheres recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
28 Oct 2026Device	CLASS II	Medtronic NDI Passive Spheres recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
28 Oct 2026Device	CLASS II	Medtronic Biopsy Needle Kit recalled by Medtronic Navigation	Medtronic Navigation	Sterility	44 states
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Other	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 1.3.0 and 1.3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Other	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Other	Nationwide
15 Nov 2023Device	CLASS I	StealthStation S8 Application recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS I	StealthStation Cranial recalled by Medtronic Navigation	Medtronic Navigation	Labeling Errors	PR
14 Jun 2023Device	CLASS I	StealthStation Cranial kits recalled by Medtronic Navigation	Medtronic Navigation	Labeling Errors	Nationwide
8 Feb 2023Device	CLASS II	AxiEM" Non-Invasive Patient Tracker recalled by Medtronic Navigation	Medtronic Navigation	Other	41 states
18 Jan 2023Device	CLASS II	RadiaLux Lighted Retractor (Pink) recalled by Medtronic Navigation	Medtronic Navigation	Sterility	Nationwide
23 Nov 2022Device	CLASS II	Visualase Cooled Laser Applicator System recalled	Medtronic Navigation	Sterility	Nationwide
29 Dec 2021Device	CLASS I	Stealthstation System w/ Stealthstation Cranial recalled	Medtronic Navigation	Device Malfunction	50 states
29 Dec 2021Device	CLASS II	Stealth Autoguide Tracker recalled by Medtronic Navigation	Medtronic Navigation	Packaging Defects	21 states
5 Aug 2020Device	CLASS II	StealthStation" S7 System with Polaris Spectra Camera recalled	Medtronic Navigation	Labeling Errors	Nationwide
17 Jun 2020Device	CLASS II	Mazor X Surgical System Positioner Type II recalled	Medtronic Navigation	Other	28 states
27 May 2020Device	CLASS I	Medtronic Nexframe Stereotactic System and StealthStation Cranial recalled	Medtronic Navigation	Labeling Errors	Nationwide
13 May 2020Device	CLASS II	Visualase Cooled Laser Applicator System Tubing Set kits recalled	Medtronic Navigation	Other	37 states
22 Apr 2020Device	CLASS II	NavLock Tracker *** recalled by Medtronic Navigation	Medtronic Navigation	Other	NY
25 Dec 2019Device	CLASS II	Medtronic Adapter Percutaneous Pin recalled by Medtronic Navigation	Medtronic Navigation	Other	Nationwide
18 Dec 2019Device	CLASS II	Passive Biopsy Needle Kit recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	50 states
18 Dec 2019Device	CLASS II	Biopsy Needle FPU Kit, Product # recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	50 states
18 Dec 2019Device	CLASS II	Biopsy Needle FPU Kit, Product # recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	50 states
9 Jan 2019Device	CLASS I	StealthStation Cranial and Synergy Cranial Depth Gauge recalled	Medtronic Navigation	Device Malfunction	50 states
3 Oct 2018Device	CLASS II	Visualase Thermal Therapy System recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	35 states
25 Jul 2018Device	CLASS II	Visualase Cooled Laser Applicator System (Vclas) labeled as recalled	Medtronic Navigation	Foreign Material	Nationwide
25 Oct 2017Device	CLASS II	Vclas (Visualase Cooled Laser Ablation System) recalled	Medtronic Navigation	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.