Brainlab recalls

Brainlab has 39 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 26 Mar 2025. 4 are still ongoing. The most frequent reason is device malfunction.

Total recalls39since 2013

Last 12 months0reported

Class I25% of total

Ongoing4latest 26 Mar 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 1 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 5%Class II 37 95%Class III 0 0%

Why brainlab is recalled

Product types

By year

202513%
202325%
202213%
202125%
2020410%
201938%
201838%
201725%
2016410%
2015923%

Ongoing brainlab recalls

4 active

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Origin Data Management recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab	Potency & Assay	TX
22 Mar 2023Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
16 Mar 2022Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	20 states

All brainlab recalls, newest first

39 total

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Origin Data Management recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab	Potency & Assay	TX
22 Mar 2023Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
16 Mar 2022Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	20 states
16 Jun 2021Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Processing Deviation	Nationwide
17 Mar 2021Device	CLASS II	ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) recalled	Brainlab	Device Malfunction	8 states
14 Oct 2020Device	CLASS II	Ultrasound Navigation recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
9 Sep 2020Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab	Other	DC, IL, OH
19 Aug 2020Device	CLASS II	Brainlab Curve; Model/catalogue (article) numbers for Curve recalled	Brainlab	Other	CA, RI, TX
19 Aug 2020Device	CLASS II	Brainlab Kick 2; Model/catalogue (article) numbers for Kick recalled	Brainlab	Other	CA, RI, TX
30 Oct 2019Device	CLASS II	Patient Data Manager recalled by Brainlab AG	Brainlab	Device Malfunction
1 May 2019Device	CLASS II	RT Elements recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
24 Apr 2019Device	CLASS I	Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation recalled	Brainlab	Device Malfunction	Nationwide
21 Mar 2018Device	CLASS II	ExacTrac versions 6.5 through 6.5 intended to be used recalled	Brainlab	Other
14 Feb 2018Device	CLASS II	AIRO Mobile CT System recalled by Brainlab AG	Brainlab	Other	Nationwide
17 Jan 2018Device	CLASS II	Navigation System Spine & Trauma 3D recalled by Brainlab AG	Brainlab	Other	KS
6 Dec 2017Device	CLASS II	Exactrac Vero recalled by Brainlab AG	Brainlab	Processing Deviation	N/A
18 Jan 2017Device	CLASS II	Femoral and Tibial Cutting Block Adapter Base recalled by Brainlab AG	Brainlab	Other	4 states
15 Jun 2016Device	CLASS II	ExacTrac Vero is a Patient Positioning System for Radiation therapy recalled	Brainlab	Other	4 states
27 Jan 2016Device	CLASS I	Cranial Navigation System: An Image Guided Surgery System recalled	Brainlab	Labeling Errors	Nationwide
20 Jan 2016Device	CLASS II	RT Elements are applications recalled by Brainlab AG	Brainlab	Other	Nationwide
20 Jan 2016Device	CLASS II	RT Elements are applications recalled by Brainlab AG	Brainlab	Other	Nationwide
25 Nov 2015Device	CLASS II	Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation recalled	Brainlab	Device Malfunction	N/A
11 Nov 2015Device	CLASS II	Digital Lightbox, BrainLAB system, image processing, radiological recalled	Brainlab	Device Malfunction	Nationwide
30 Sep 2015Device	CLASS II	Disposable Reflective Marker Spheres The Disposable recalled	Brainlab	Packaging Defects	Nationwide
2 Sep 2015Device	CLASS II	ExacTrac 6.0.x Patient Positioning System, Radiation therapy recalled	Brainlab	Other	31 states
13 May 2015Device	CLASS II	ExacTrac 6.x recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
1 Apr 2015Device	CLASS II	ExacTrac versions 6.x patient positioning systems are used recalled	Brainlab	Other
4 Mar 2015Device	CLASS II	Offset Cup Impactor Universal recalled by Brainlab AG	Brainlab	Sterility	Nationwide
21 Jan 2015Device	CLASS II	iPlan RT Dose is a stereotactic radiation treatment recalled	Brainlab	Device Malfunction	45 states

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.