Browse Device Recalls
39 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2025 | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | Under certain circumstances, it can occur that patient records from unrelated individuals are aut... | Class II | Brainlab AG |
| Mar 2, 2023 | Cirq Arm System 2.0 | Risk of mechanical instability due to potential manufacturing error of the device | Class II | Brainlab AG |
| Feb 14, 2023 | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therap... | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a stand... | Class II | Brainlab AG |
| Feb 25, 2022 | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon... | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | Class II | Brainlab AG |
| May 14, 2021 | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Ins... | Display of potential patient movement might be delayed to the user for high dose treatments. | Class II | Brainlab AG |
| Mar 1, 2021 | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). | In case of a failed automatic marker detection, a software error causes parts of the display to ... | Class II | Brainlab AG |
| Aug 31, 2020 | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cr... | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image wi... | Class II | Brainlab AG |
| Aug 20, 2020 | Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56... | Holding force of the Positioning Arm can be reduced by prolonged non-use. | Class II | Brainlab AG |
| Jul 16, 2020 | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; ... | Incorrect manufacturer calibration | Class II | Brainlab AG |
| Jul 16, 2020 | BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 U... | Incorrect manufacturer calibration | Class II | Brainlab AG |
| Sep 25, 2019 | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MAN... | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Crani... | Class II | Brainlab AG |
| Mar 11, 2019 | RT Elements Software revisions of the RT Elements applications have a speci... | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements softw... | Class II | Brainlab AG |
| Feb 27, 2019 | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software ... | In certain occurrences, the affected navigation software application might unexpectedly display a... | Class I | Brainlab AG |
| Feb 14, 2018 | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an... | The usage of workflows that deviate from the recommended specifications in the User manual for Ex... | Class II | Brainlab AG |
| Nov 16, 2017 | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLin... | Due to a human error at a supplier, an unknown number of devices within one specific production l... | Class II | Brainlab AG |
| Nov 3, 2017 | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 462... | Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly a... | Class II | Brainlab AG |
| Jul 28, 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is... | Risk of unintended motion while the AIRO system is in transport mode. | Class II | Brainlab AG |
| Oct 27, 2016 | Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image ... | Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific seri... | Class II | Brainlab AG |
| May 4, 2016 | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Ve... | Class II | Brainlab AG |
| Nov 5, 2015 | RT Elements are applications for radiation treatment planning for use in ster... | Large objects with fine resolution are potentially displayed cropped when imported into Brainlab ... | Class II | Brainlab AG |
| Nov 5, 2015 | RT Elements are applications for radiation treatment planning for use in ster... | Large objects with fine resolution are potentially displayed cropped when imported into Adaptive ... | Class II | Brainlab AG |
| Sep 21, 2015 | Digital Lightbox, BrainLAB system, image processing, radiological Product ... | Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. | Class II | Brainlab AG |
| Aug 18, 2015 | Disposable Reflective Marker Spheres The Disposable Reflective Marker Sphe... | Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS... | Class II | Brainlab AG |
| Aug 5, 2015 | ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to... | ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructe... | Class II | Brainlab AG |
| May 8, 2015 | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation... | Instances of data sets not being accurately registered to the patient anatomy were observed. | Class II | Brainlab AG |
| Mar 6, 2015 | ExacTrac 6.x. is software used to place patients at an accurately defined poi... | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the... | Class II | Brainlab AG |
| Feb 16, 2015 | ExacTrac versions 6.x patient positioning systems are used to position patien... | The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the E... | Class II | Brainlab AG |
| Jan 16, 2015 | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system.... | The recommended sterilization and drying parameters are not effective to achieve the minimum requ... | Class II | Brainlab AG |
| Nov 19, 2014 | iPlan RT Dose is a stereotactic radiation treatment planning system that is i... | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when us... | Class II | Brainlab AG |
| Nov 19, 2014 | iPlan RT is a radiation treatment planning system that is intended for use in... | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when us... | Class II | Brainlab AG |
| Jun 27, 2014 | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Vi... | The following defects have been identified for data loaded with Patient Data Manager version 2.0 ... | Class II | Brainlab AG |
| Jun 24, 2014 | ExacTrac is intended to be used to place patients at an accurately defined po... | When using multiple isocenters (radiation treatment targets) within a single plan, in certain wor... | Class II | Brainlab AG |
| May 21, 2014 | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intrao... | Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intra... | Class II | Brainlab AG |
| Apr 15, 2014 | ExacTrac 5.5, an Image Processing System used for patient positioning for rad... | When using a specific plan update workflow in combination with a non-Brainlab treatment planning ... | Class II | Brainlab AG |
| Feb 24, 2014 | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalog... | When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might ... | Class II | Brainlab AG |
| Nov 18, 2013 | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag... | The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows ... | Class II | Brainlab AG |
| Nov 15, 2013 | BrainLAB's VectorVision spine is intended for use as an intraoperative image-... | Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with sp... | Class II | Brainlab AG |
| Jul 16, 2013 | BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to com... | The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose ... | Class II | Brainlab AG |
| Apr 22, 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... | Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... | Class I | Brainlab AG |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.