Brainlab AG recalls

Brainlab AG 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

0Oct '24 0 0 0Jan '25 0 1 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

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

Why brainlab ag is recalled

Product types

By year

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

Ongoing brainlab ag recalls

4 active

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

All brainlab ag recalls, newest first

39 total

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Origin Data Management recalled by Brainlab AG	Brainlab AG	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab AG	Potency & Assay	TX
22 Mar 2023Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab AG	Device Malfunction	Nationwide
16 Mar 2022Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab AG	Device Malfunction	20 states
16 Jun 2021Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab AG	Processing Deviation	Nationwide
17 Mar 2021Device	CLASS II	ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) recalled	Brainlab AG	Device Malfunction	8 states
14 Oct 2020Device	CLASS II	Ultrasound Navigation recalled by Brainlab AG	Brainlab AG	Device Malfunction	Nationwide
9 Sep 2020Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab AG	Other	DC, IL, OH
19 Aug 2020Device	CLASS II	Brainlab Curve; Model/catalogue (article) numbers for Curve recalled	Brainlab AG	Other	CA, RI, TX
19 Aug 2020Device	CLASS II	Brainlab Kick 2; Model/catalogue (article) numbers for Kick recalled	Brainlab AG	Other	CA, RI, TX

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.