Browse Device Recalls
3,099 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,099 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 3,099 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 6, 2015 | VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | Assay Data Disk (ADD), All DRV versions that support product within expiry da... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 1, 2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the ... | Class II | Dako North America Inc. |
| Apr 1, 2015 | Patient Handling System (Motion Control Software), Product Usage: Indica... | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS... | Class II | Viewray Incorporated |
| Mar 27, 2015 | The eCareManager system. Software intended for use in data collection, stora... | A software defect may cause incorrect medication order change. If the user decides to edit the o... | Class II | Visicu, Inc. |
| Mar 25, 2015 | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | Device software treatment preset parameters for the XC treatment handpiece do not match the Opera... | Class II | Lumenis Limited |
| Mar 25, 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charg... | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Mar 24, 2015 | Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers fo... | Customer reports that the ventilator display can freeze. Ventilation continues but the informatio... | Class II | Hamilton Medical, Inc. |
| Mar 23, 2015 | Sedecal SA Mobile Diagnost w DR x-ray system | Due to a software defect, the system may sporadically apply the default x ray exposure parameters... | Class II | Sedecal USA, Inc. |
| Mar 12, 2015 | Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A... | Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is ... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Mar 10, 2015 | Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Numb... | Software Anomaly; It is possible for the device to process samples with a cartridge other than th... | Class II | Ortho-Clinical Diagnostics |
| Mar 9, 2015 | GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INF... | GE Healthcare has become aware of a potential safety issue involving MRI systems due to software ... | Class II | GE Healthcare |
| Mar 9, 2015 | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indic... | The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that g... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 6, 2015 | ExacTrac 6.x. is software used to place patients at an accurately defined poi... | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the... | Class II | Brainlab AG |
| Mar 5, 2015 | Merge LIS software. | There is a potential for duplicate container numbers to be created for patients. | Class II | Merge Healthcare, Inc. |
| Mar 4, 2015 | RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, Ra... | An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is ... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 2, 2015 | Master Drug Library Software version 8.0, Product Code 35723V080, to be used ... | Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump d... | Class II | Baxter Healthcare Corp |
| Feb 23, 2015 | Mobius3D Product Usage: Mobius3D software is used for quality assurance a... | Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam c... | Class II | Mobius Medical Systems, LP |
| Feb 20, 2015 | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - Internat... | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parame... | Class II | Optimedica Corporation |
| Feb 19, 2015 | AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small... | STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will ... | Class II | Steris Corporation |
| Feb 18, 2015 | The Spirit TM Select bed is a Med-Surg bed intended to support and transport ... | It was identified that in some situations the bed exit alarm may not function as intended. The so... | Class II | CHG Hospital Beds Inc |
| Feb 11, 2015 | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Versio... | Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 6, 2015 | SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA... | Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technol... | Philips discovered that a software defect exists in marketed product wherein the sign indication ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 4, 2015 | FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Ar... | Measurement values in the EMR may not accurately reflect the actual measurement value on the Syna... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Feb 2, 2015 | COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, ... | Error in the software. During internal tests of the current development version of the Compass ... | Class II | Iba Dosimetry Gmbh |
| Jan 22, 2015 | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3... | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of t... | Class II | Carl Zeiss Meditec AG |
| Jan 21, 2015 | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 | A device malfunction may cause the biopsy needle to fail to reach the intended target. If locatio... | Class II | iCAD, Inc. |
| Jan 21, 2015 | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Pict... | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Modu... | Class II | TeraRecon, Inc. |
| Jan 21, 2015 | Siemens LANTIS Oncology Information System Servers; allows the radiation the... | There is a potential safety risk when using LANTIS server software with operating systems with wh... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 15, 2015 | ViewRay System, Radiation Therapy System | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) ... | Class II | Viewray Incorporated |
| Jan 14, 2015 | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery s... | Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certa... | Class II | INO Therapeutics (dba Ikaria) |
| Jan 2, 2015 | EPWorks software used in the Xltek Protektor Stimulator Product Usage: In... | Software error occurs when using remote monitoring; if the remote user tries to stop the free run... | Class II | Natus Medical Incorporated |
| Jan 2, 2015 | EPWorks software used in the Protektor 32 Product Usage: Uses electroence... | Software error occurs when using remote monitoring; if the remote user tries to stop the free run... | Class II | Natus Medical Incorporated |
| 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 |
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.