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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.