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 |
|---|---|---|---|---|
| Apr 20, 2015 | SOMATOM Emotion 6; the intended use of computed tomography is to produce cros... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) | The operator console allows users to deliver therapeutic radiation to patients even though a spec... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Apr 14, 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer applicat... | The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could... | Class II | bioMerieux, Inc. |
| Apr 14, 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24,... | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail... | Class II | Nihon Kohden America Inc |
| Apr 14, 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity CT Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 13, 2015 | SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system,... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fl... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2015 | Merge RadSuite software. Radiological image processing system. | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ... | Class II | Merge Healthcare, Inc. |
| Apr 8, 2015 | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Editi... | Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possib... | Class II | Baxter Corporation Englewood |
| 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 |
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.