Imactis recalls

Imactis has 3 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 24 Mar 2021. 2 are still ongoing. The most frequent reason is labeling errors.

Total recalls3since 2020

Last 12 months0reported

Class I00% of total

Ongoing2latest 24 Mar 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why imactis is recalled

Product types

Other Medical Devices267%
Syringes & Needles133%

By year

2021133%
2020267%

Ongoing imactis recalls

2 active

Reported	Class	Recall	Company	Reason	Where
23 Sep 2020Device	CLASS II	Patient Fiducial (Patient Referential) recalled by Imactis	Imactis	Lead & Heavy Metals	Nationwide
29 Jan 2020Device	CLASS II	Navigation Kit recalled by Imactis	Imactis	Sterility	IL, WI

All imactis recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
24 Mar 2021Device	CLASS II	Impactis NaviKit-stereotaxic accessory recalled by Imactis	Imactis	Labeling Errors	NJ, NY, WI
23 Sep 2020Device	CLASS II	Patient Fiducial (Patient Referential) recalled by Imactis	Imactis	Lead & Heavy Metals	Nationwide
29 Jan 2020Device	CLASS II	Navigation Kit recalled by Imactis	Imactis	Sterility	IL, WI

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.