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
Sep 16, 2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 11, 2013 The Artis zee / zeego Angiography System is designed as a set of components t... There is a potential issue on running Artis systems running software VC1x software if a network p... Class II Siemens Medical Solutions USA, Inc
Sep 6, 2013 Selenia Full Field Digital Mammography System with software versions 5.0.x an... Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the ... Class II Hologic, Inc.
Sep 4, 2013 McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, ... Software malfunction may occur resulting in a certain combination of server configurations which ... Class II Mckesson Information Solutions LLC
Sep 3, 2013 Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software ve... When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... Class II Siemens Medical Solutions USA, Inc
Sep 3, 2013 ADVIA 2400 System Software V4.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1800 System Software V2.01. Performs assays for general and specialt... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Sep 3, 2013 (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Urosko... A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos... Class II Siemens Medical Solutions USA, Inc
Sep 3, 2013 ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for genera... Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... Class II Siemens Healthcare Diagnostics
Aug 29, 2013 DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. b... Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... Class II Carestream Health Inc.
Aug 29, 2013 CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A.... Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... Class II Carestream Health Inc.
Aug 28, 2013 Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with sof... When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... Class II Siemens Medical Solutions USA, Inc
Aug 26, 2013 Merge Mammo is a multi-modality, vendor-neutral digital mammography workstati... There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo vie... Class II GE Healthcare It
Aug 20, 2013 FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or... The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data fr... Class III Bio-Rad Laboratories
Aug 16, 2013 Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... Class II Philips Medical Systems (Cleveland) Inc
Aug 9, 2013 WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... Class III Copan Italia
Aug 1, 2013 NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.... Under certain circumstances, the Left eye image may be saved as the Right eye image. Class II Nidek Inc
Jul 26, 2013 DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY... During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an a... Class II Carestream Health, Inc.
Jul 25, 2013 DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone softw... An anomaly was detected such that, under certain conditions, a summed dose created by Velocity re... Class II Velocity Medical Solutions, LLC
Jul 15, 2013 StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... Class II Medtronic Navigation, Inc.
Jul 10, 2013 Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M... Software issue results in inaccurate 3D image may result in ablation in wrong location. Class II Siemens Medical Solutions USA, Inc.
Jul 1, 2013 Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performan... The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013 CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used wit... The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013 RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and T... The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... Class II Stryker Instruments Div. of Stryker Corporation
Jun 26, 2013 ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21... Siemens issued a customer safety advisory notice and field safety corrective action for a potenti... Class II Siemens Medical Solutions USA, Inc
Jun 21, 2013 MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e... Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue asso... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Jun 21, 2013 Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2... Notes associated with prescription are not printed to the prescription or to the patient chart. Class II Picis Inc.
Jun 20, 2013 TDHistology/Cytology Classification name: Calculator/data processing modul... A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... Class III Technidata S.A.
Jun 19, 2013 Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Disp... Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems... Class II Siemens Healthcare Diagnostics, Inc.
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 12, 2013 The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibril... The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to... Class II Physio Control, Inc.
Jun 7, 2013 Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer... Class II Del Mar Reynolds Medical, Ltd.
Jun 4, 2013 Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 1... Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue wit... Class I Respironics California Inc
Jun 3, 2013 AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Soft... The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyz... Class II Beckman Coulter Inc.
May 24, 2013 MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalm... Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory fun... Class II Nidek 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.