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 8, 2014 | VITROS 5600 Integrated System, System Product Code 6802413. For use in the... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 5, 2014 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | The software issue described was corrected in the modification to the MXTTOUT controller paramete... | Class II | Zimmer Biomet, Inc. |
| Sep 1, 2014 | Fluid Management System P4000; for irrigation and fluid warming in laparosco... | To correct software bugs that could affect the ability to accurately measure fluid deficit. | Class II | Thermedx LLC |
| Aug 29, 2014 | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... | Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has d... | Class II | Dako North America Inc. |
| Aug 28, 2014 | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components ... | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studie... | Class II | Merge Healthcare, Inc. |
| Aug 27, 2014 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic mon... | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglo... | Class II | Mckesson Information Solutions LLC |
| Aug 27, 2014 | The Ysio Systems with software version VC10 The Ysio enables radiographic ... | Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 25, 2014 | EpiCenter Plus Microbiology Data Management System software version 6.20A, wh... | The information in the EpiCenter interface translation tables was not updated to match the Bruker... | Class II | Becton Dickinson & Co. |
| Aug 21, 2014 | TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In... | The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen ... | Class II | Maquet Medical Systems USA |
| Aug 21, 2014 | Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions... | When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView,... | Class II | Philips Medical Systems, Inc. |
| Aug 19, 2014 | Siemens CentraLink Data Management System, software version 14. The Cent... | Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Da... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2014 | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JR... | Potential issues with the ProVue driver have been identified which may cause data to be misassoci... | Class II | Data Innovations, LLC |
| Aug 13, 2014 | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ... | BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th... | Class III | Biofire Defense |
| Aug 12, 2014 | The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | The Siemens Symbia T series is intended for use by appropriately trained heal... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | The Siemens Symbia S series is intended for use by appropriately trained heal... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 7, 2014 | Philips IntelliSpace ECG Management System, with software option C61 needed ... | Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Q... | Class II | Philips Medical Systems, Inc. |
| Jul 31, 2014 | Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th... | It was discovered that a software defect may result in the scanner not terminating the CT scan a... | Class II | Philips Medical Systems, Inc. |
| Jul 31, 2014 | Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 45356044604... | Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 ... | Class II | Philips Electronics North America Corporation |
| Jul 28, 2014 | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... | Class II | Illumina Inc |
| Jul 27, 2014 | IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli... | The following software issues have been identified in the affected products. Problem 1: When reo... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 24, 2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image... | A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... | Class II | Philips Healthcare Informatics, Inc. |
| Jul 17, 2014 | Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ... | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2014 | Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other elect... | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jul 17, 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... | Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (H... | Class II | TomoTherapy Incorporated |
| Jul 16, 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... | Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ ... | Class II | TomoTherapy Incorporated |
| Jul 15, 2014 | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vit... | Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrec... | Class II | Ab Sciex |
| Jul 9, 2014 | QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a softw... | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... | Class II | Philips Ultrasound, Inc. |
| Jul 9, 2014 | QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a sof... | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... | Class II | Philips Ultrasound, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 7, 2014 | VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF ... | It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 7, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VIT... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative,... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 5, 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medica... | Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, t... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Jul 3, 2014 | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS i... | In specific situation a partially truncated file may be written to the IntelePACS server. This p... | Class II | Intelerad Medical Systems |
| Jul 1, 2014 | Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. ... | The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP ... | Class II | Ansar Group, Inc. Dba Ansar Medical Technologie... |
| Jun 27, 2014 | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... | Potential for demographic information and test result to be mismatch. | Class II | PerkinElmer Health Sciences, Inc. |
| Jun 27, 2014 | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Vi... | The following defects have been identified for data loaded with Patient Data Manager version 2.0 ... | Class II | Brainlab AG |
| Jun 18, 2014 | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.0... | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely... | Class II | Spacelabs Healthcare Inc |
| Jun 17, 2014 | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMEN... | Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncolo... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 13, 2014 | GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PD... | Class II | GE Healthcare, LLC |
| Jun 12, 2014 | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade ... | Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in ... | Class II | Biolase Technology Inc |
| Jun 11, 2014 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... | Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... | Class I | GE Healthcare, LLC |
| Jun 10, 2014 | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... | If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... | Class II | Baxter Healthcare Corp. |
| Jun 6, 2014 | Philips Medical System Allura Xper X-Ray Angiographic | In certain circumstances, a software error can lead to a situation where the five minute fluorosc... | Class II | Philips Medical Systems, Inc. |
| Jun 6, 2014 | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ... | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg... | Class II | Hospira Inc. |
| Jun 5, 2014 | Artis zee and Artis zeego systems. x-ray, angiographic system | There is a potential problem with Artis zee and Artis zeego systems running software version VC21... | 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.