Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls.

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DateProductReasonClassFirm
Jul 27, 2015 Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to meas... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to mea... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to ... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to m... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to ... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to mea... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 27, 2015 Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to me... Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... Class II Transonic Systems Inc
Jul 23, 2015 Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a... The software is unable to accurately determine the calcium score of scans with a slice thickness ... Class II Merge Healthcare, Inc.
Jul 17, 2015 MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Cat... The software incorrectly allows the operator to manually edit the carbohydrate substrates when ma... Class II Beckman Coulter Inc.
Jul 3, 2015 nordicICE v 2.3.14 nordicICE is an image processing software package to be... The bug causes BOLD activation maps to be visualized as overlays without taking the coregistrati... Class II NordicNeuroLab AS
Jul 1, 2015 GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems ar... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a ... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems a... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Syste... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jun 30, 2015 PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Pr... Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are ... Class II BIOTRONIK, Inc.
Jun 30, 2015 VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software... Class II Ortho-Clinical Diagnostics
Jun 26, 2015 Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8... Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated... Class III Getinge Disinfection Ab
Jun 25, 2015 ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with softw... Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual t... Class II Siemens Medical Solutions USA, Inc.
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 15, 2015 OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1... Software bug was found where there was no difference in Total and Corneal high-order aberrations,... Class II Nidek Inc
Jun 5, 2015 Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStar... Multiple software and hardware issues with device that can affect its function. Class II Philips Electronics North America Corporation
May 31, 2015 The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2... Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to f... Class II Merge Healthcare, Inc.
May 29, 2015 Radiation Therapy Treatment Planning System software RayStation is a softw... An error caused by a floating point precision problem tends to cause a problem with the display o... Class II RAYSEARCH LABORATORIES AB
May 29, 2015 ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A an... When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of d... Class II Siemens Medical Solutions USA, Inc.
May 22, 2015 Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego system... There exists a possible position sensor fault in the swivel base axis not being detected by the s... Class II Siemens Medical Solutions USA, Inc
May 21, 2015 Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimensi... Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop process... Class II Siemens Healthcare Diagnostics, Inc.
May 21, 2015 Oncentra Brachy radiation therapy planning software designed to analyze and p... Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. Class II Elekta, Inc.
May 19, 2015 CentraLink" Data Management System; software is a network solution provider a... Siemens Healthcare Diagnostics has determined that the sample query function that includes Instr... Class II Siemens Healthcare Diagnostics, Inc.
May 15, 2015 Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catal... Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or hi... Class II Philips Ultrasound, Inc.
May 15, 2015 Syngo.via and Syngo.x ; a software solution intended to be used for viewing, ... measurements drawn on the 2nd and subsequent images of the series are not visible on printouts wh... Class II Siemens Medical Solutions USA, Inc
May 13, 2015 Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... An issue with the cancel functionality used during atypical infusion programming to cancel user i... Class II CareFusion 303, Inc.
May 8, 2015 RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment P... RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VM... Class II RAYSEARCH LABORATORIES AB
May 8, 2015 Celesteion PCA-9000A/2 PET/CT System It was found that if specific operations are performed in multi-phase helical scanning, the acqui... Class II Toshiba American Medical Systems Inc
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
May 7, 2015 Treatment Planning and Delivery System Software version 3.6. ViewRay. Ind... The software was failing to determine new patient locations if imaging is not enabled during trea... Class II Viewray Incorporated
May 2, 2015 NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e,... It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1... Class II Neusoft Medical Systems Co., Ltd.
Apr 29, 2015 EasyLink Data Management System; a clinical data management system that assis... System Limitations and Software Issues related to the following features: Custom reference range... Class II Siemens Healthcare Diagnostics, Inc.
Apr 23, 2015 Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The ... A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in th... Class II Philips Medical Systems, Inc.
Apr 20, 2015 SOMATOM Perspective; the intended use of computed tomography is to produce cr... Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2015 SOMATOM Emotion 16, the intended use of computed tomography is to produce cro... Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... Class II Siemens Medical Solutions USA, Inc

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.