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 |
|---|---|---|---|---|
| Dec 19, 2014 | Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i... | Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification | Class II | Philips Medical Systems, Inc. |
| Dec 19, 2014 | McKesson Cardiology ECG Management It is a software application designed t... | An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG ... | Class II | McKesson Israel Ltd. |
| Dec 18, 2014 | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver... | Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud... | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Dec 16, 2014 | ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x... | Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 15, 2014 | Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 an... | Potential for composed images to be flipped before being sent to PACS on systems with software v... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 15, 2014 | nordicTumorEx 1.0 nordicTumorEx is an image processing software package ... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Dec 4, 2014 | Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joi... | The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to... | Class II | Hansen Medical Inc |
| Dec 2, 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-... | Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (Ex... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Nov 25, 2014 | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog ... | While servicing a unit at a customer site, a field engineer discovered a broken bolt from the car... | Class II | Carestream Health Inc |
| Nov 21, 2014 | TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (H... | Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System ... | Class II | TomoTherapy Incorporated |
| Nov 20, 2014 | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-0... | During an investigation of instrument logs it was determined that In specific circumstances invol... | Class II | Phadia US Inc |
| Nov 19, 2014 | iPlan RT Dose is a stereotactic radiation treatment planning system that is i... | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when us... | Class II | Brainlab AG |
| Nov 19, 2014 | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower... | HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 ... | Class II | Horiba Instruments Inc |
| Nov 19, 2014 | VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Nu... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The... | There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mAR... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2014 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho C... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | iPlan RT is a radiation treatment planning system that is intended for use in... | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when us... | Class II | Brainlab AG |
| Nov 13, 2014 | Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Unive... | It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using ... | Class II | Illumina Inc |
| Nov 12, 2014 | The Revolution CT is a multi-slice (256 detector row) CT scanner consisting o... | A required quality control test was not performed during installation associated with the softwar... | Class II | GE Healthcare |
| Nov 12, 2014 | BrightView model number: 882478 BrightView X model number: 882480 BrightVie... | Unintended detector and gantry movement due to software issues. | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 11, 2014 | AlignRT is a video-based three-dimensional (3D) surface imaging system which ... | Potential use error when the external Gate Controller is turned ON after the Vision RT software... | Class II | Vision Rt Inc |
| Nov 10, 2014 | MEVION S250, used for proton radiation therapy. | Software defect that causes an incorrect dose compensation function to be applied to the internal... | Class II | Mevion Medical Systems, Inc. |
| Nov 10, 2014 | CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software... | The firm is informing customers of a software error that might result in an inaccurate display of... | Class III | Medtronic MiniMed Inc. |
| Nov 9, 2014 | IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/... | Software defect. In certain circumstances, the application may display incorrect measurements of... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 6, 2014 | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost... | Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u... | Class III | Illumina Inc |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | BrightView product code: 882478 BrightView X product code: 882480 BrightVie... | Software issues | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 31, 2014 | CyberKnife Robotic Radiosurgery System with the first generation IRIS Variabl... | Software upgrade to correct potential safety issue related to CyberKnife System that occurs when ... | Class II | Accuray Incorporated |
| Oct 30, 2014 | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images th... | Reduced mammographic image quality when attempting to print true size multi-format images | Class II | Carestream Health, Inc. |
| Oct 23, 2014 | Abbott m2000sp, an automated system for performing sample preparation for nuc... | Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw... | Class II | Abbott Molecular |
| Oct 23, 2014 | JResultNet drivers using ASTM coding language. Calculator/data processing mo... | Software issue resulting in the results of one patient potentially being associated with another. | Class II | Data Innovations, LLC |
| Oct 17, 2014 | Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid... | Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Oct 17, 2014 | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0... | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid... | Class II | INO Therapeutics (dba Ikaria) |
| Oct 3, 2014 | Philips Avalon Monitors with software revision J.30.58: Model Product F... | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... | Class II | Philips Medical Systems, Inc. |
| Oct 3, 2014 | Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo... | Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB... | Class II | Philips Medical Systems, Inc. |
| Oct 1, 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... | A software issue may lead to ventilator inoperative situations. | Class I | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 29, 2014 | CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-... | Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"... | Class II | Smiths Medical ASD, Inc. |
| Sep 25, 2014 | COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear ... | Error in the software. A deviation between reconstructed and planned dose distribution may not b... | Class II | Iba Dosimetry Gmbh |
| Sep 17, 2014 | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical... | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass... | Class II | Intuitive Surgical, Inc. |
| Sep 12, 2014 | nordicICE 2.3.14 Image processing software package used by trained profess... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
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.