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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2019 | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully i... | code 7-102 Liquid Sensor Error | Class II | Phadia Ab |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 350 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 4600 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 4600 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250AT Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... | The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encou... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 3, 2019 | SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomograph... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of... | Class II | Elekta Inc |
| Jul 3, 2019 | SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tom... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomo... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography sys... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography sys... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomogra... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2019 | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (T... | QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate I... | Class II | Qiagen Sciences LLC |
| Jun 24, 2019 | Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag... | The QA software solution to perform the MR to MV alignment check, does not display the stored MR ... | Class II | Elekta, Inc. |
| Jun 24, 2019 | VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1... | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... | Class I | Fenwal Inc |
| Jun 24, 2019 | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod... | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... | Class I | Fenwal Inc |
| Jun 19, 2019 | iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 | Potential for iGUIDE to incorrectly monitor the 3D position. | Class II | Elekta, Inc. |
| Jun 10, 2019 | Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... | Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci seri... | Class II | Abbott Gmbh & Co. KG |
| Jun 4, 2019 | SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 23, 2019 | Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software v... | During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscr... | Class II | Obalon Therapeutics Inc |
| May 21, 2019 | The Alinity ci-series System Control Modules which are configured with Alinit... | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... | Class II | Abbott Gmbh & Co. KG |
| May 20, 2019 | Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... | Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... | Class II | Medtronic Inc. |
| May 20, 2019 | The Visibly Online Refractive Vision Test which is part of the Visibly Vision... | Lack of 510K clearance | Class II | Opternative Inc |
| May 17, 2019 | Beckman Coulter Power Express Sample Processing System AU5800XL connection un... | Potential exposure to biohazard. Software design problem causes excess speed and vibrations in... | Class II | Beckman Coulter Inc. |
| May 16, 2019 | Centricity PACS Foundation Centricity PACS software product is intended fo... | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... | Class II | GE Healthcare, LLC |
| May 3, 2019 | AUTION HYBRID AU-4050 | This correction is being initiated due to a software issue which results in the possibility of in... | Class II | Arkray Factory USA, Inc. |
| Apr 29, 2019 | Philips Patient Information Center iX configured with a regional setting whic... | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... | Class III | Philips North America, LLC |
| Apr 29, 2019 | Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Model... | There is a potential that the image of one patient could get unexpectedly moved into another pati... | Class II | Philips Ultrasound Inc |
| Apr 19, 2019 | SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiolog... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological p... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the phys... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the p... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
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.