Browse Device Recalls

3,235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,235 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 3,235 FDA device recalls.

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DateProductReasonClassFirm
Jan 28, 2019 ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens M... The action is being initiated due to internal testing which identified a possibility for transduc... Class II Siemens Medical Solutions USA, Inc.
Jan 28, 2019 ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Si... The action is being initiated due to internal testing which identified a possibility for transduc... Class II Siemens Medical Solutions USA, Inc.
Jan 28, 2019 ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens ... The action is being initiated due to internal testing which identified a possibility for transduc... Class II Siemens Medical Solutions USA, Inc.
Jan 28, 2019 ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Sie... The action is being initiated due to internal testing which identified a possibility for transduc... Class II Siemens Medical Solutions USA, Inc.
Jan 17, 2019 MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 10, 2019 EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management S... User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling ... Class II Bio-Rad Laboratories, Inc
Jan 9, 2019 PageWriter TC50 Government Bundle, Product 860429, Software revisions up to a... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revis... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisio... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisi... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revis... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC30, Product 860306, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC20, Product 860332, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC50, Product 860310, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70, Product 860315, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P... For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, th... Class II NEUSOFT MEDICAL SYSTEMS IMP & EX
Jan 2, 2019 BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ... Class III Becton, Dickinson and Company, BD Biosciences
Dec 20, 2018 AMSCO 3000 Series Washer/Disinfector Model # 3052 The software in the systems may not process the cycle originally intended. This could result in d... Class II Steris Corporation
Dec 20, 2018 AMSCO 5000 Series Washer/Disinfector Model # 5052 The software in the systems may not process the cycle originally intended. This could result in d... Class II Steris Corporation
Dec 19, 2018 Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn... A software update is being issued to correct multiple issues identified in the previous software ... Class II Philips Medical Systems (Cleveland) Inc
Dec 11, 2018 AMIA Automated Peritoneal Dialysis System Product Usage: It is intended ... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 11, 2018 Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... Class II Carl Zeiss Meditec, Inc.
Dec 5, 2018 The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 5, 2018 UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 4, 2018 Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t... Class III Stryker Instruments Div. of Stryker Corporation
Dec 4, 2018 DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is ... After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which t... Class II Agfa-Gevaert, N.V.
Dec 3, 2018 C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ... The Controller does not detect overpressure in the balloon during the application of non-dosing p... Class II PENTAX of America Inc
Nov 30, 2018 System, Tomography Computed Emmission GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... Class II GE Healthcare, LLC
Nov 30, 2018 System, Tomography Computed Emmission GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... Class II GE Healthcare, LLC
Nov 30, 2018 Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Philips has discovered through customer complaints and internal testing an intermittent electroni... Class II Philips Medical Systems Nederlands
Nov 29, 2018 Sensis Vibe System, Model Number 11007642, with software version VD10B. A software error may result in a system crash. The system must be restarted before the clinical ... Class II Siemens Medical Solutions USA, Inc
Nov 16, 2018 The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... Lead impedance values reported by the affected VNS generator will be higher compared to those rep... Class II LivaNova USA Inc
Nov 16, 2018 VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly This recall is being initiated due to reports that that the therapy programming tablet with softw... Class II LivaNova USA Inc
Nov 15, 2018 Various GE Magnetic Resonance System on-site software version Product Usag... Possible incorrect software version loaded. Class II GE Healthcare, LLC
Nov 15, 2018 Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1... There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plott... Class II Philips Electronics North America Corporation
Nov 13, 2018 VITEK¿ 2 Systems Software Version 9.01 Update Kit. The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification... Class II bioMerieux, Inc.
Nov 9, 2018 Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, ... Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and ... Class II GE Healthcare, LLC
Nov 7, 2018 Philips Volcano FFR software used in the following systems connected to the M... Interoperability issue that affects certain systems that use the recalled software when it is con... Class II Volcano Corporation
Oct 22, 2018 NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-S... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT ... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 19, 2018 VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vi... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in th... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 16, 2018 Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend... Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... Class II Siemens Healthcare Diagnostics, Inc.
Oct 16, 2018 Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... software malfunction; It was found when a user performs radiography using the wireless flat pane... Class II Canon Medical System, USA, INC.
Oct 16, 2018 Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende... Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... Class II Siemens Healthcare Diagnostics, Inc.
Oct 15, 2018 Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software... Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured p... Class II Smiths Medical ASD 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.