Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 30, 2018 | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... | Class II | GE Healthcare, LLC |
| Nov 30, 2018 | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou... | Class II | GE Healthcare, LLC |
| Nov 30, 2018 | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Philips has discovered through customer complaints and internal testing an intermittent electroni... | Class II | Philips Medical Systems Nederlands |
| Nov 29, 2018 | Sensis Vibe System, Model Number 11007642, with software version VD10B. | A software error may result in a system crash. The system must be restarted before the clinical ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 16, 2018 | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... | Lead impedance values reported by the affected VNS generator will be higher compared to those rep... | Class II | LivaNova USA Inc |
| Nov 16, 2018 | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly | This recall is being initiated due to reports that that the therapy programming tablet with softw... | Class II | LivaNova USA Inc |
| Nov 15, 2018 | Various GE Magnetic Resonance System on-site software version Product Usag... | Possible incorrect software version loaded. | Class II | GE Healthcare, LLC |
| Nov 15, 2018 | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1... | There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plott... | Class II | Philips Electronics North America Corporation |
| Nov 13, 2018 | VITEK¿ 2 Systems Software Version 9.01 Update Kit. | The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification... | Class II | bioMerieux, Inc. |
| Nov 9, 2018 | Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, ... | Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and ... | Class II | GE Healthcare, LLC |
| Nov 7, 2018 | Philips Volcano FFR software used in the following systems connected to the M... | Interoperability issue that affects certain systems that use the recalled software when it is con... | Class II | Volcano Corporation |
| Oct 22, 2018 | NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... | Class II | Neusoft Medical Systems Co., Ltd. |
| Oct 22, 2018 | NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-S... | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... | Class II | Neusoft Medical Systems Co., Ltd. |
| Oct 22, 2018 | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT ... | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... | Class II | Neusoft Medical Systems Co., Ltd. |
| Oct 19, 2018 | VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vi... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 19, 2018 | VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vit... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 19, 2018 | VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in th... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 19, 2018 | VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vit... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 16, 2018 | Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend... | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 16, 2018 | Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... | software malfunction; It was found when a user performs radiography using the wireless flat pane... | Class II | Canon Medical System, USA, INC. |
| Oct 16, 2018 | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende... | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 15, 2018 | Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software... | Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured p... | Class II | Smiths Medical ASD Inc. |
| Oct 9, 2018 | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2... | This recall has been initiated due to a software defect found in the Guide System software when u... | Class I | Synaptive Medical Inc |
| Oct 3, 2018 | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... | Class II | Medtronic Inc. |
| Oct 2, 2018 | Medtronic CareLink 2090 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual wit... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 2, 2018 | Medtronic CareLink Encore 29901 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual wit... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 1, 2018 | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Up... | Class II | Medical Components, Inc dba MedComp |
| Sep 28, 2018 | Tosoh AIA-900 immunoassay Analyzer | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to... | Class II | Tosoh Bioscience Inc |
| Sep 26, 2018 | Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specim... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens.... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View usin... | Class I | Medtronic Navigation, Inc. |
| Sep 24, 2018 | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo... | Class II | Invivo Corporation |
| Sep 24, 2018 | PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fi... | Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3... | Class II | PerkinElmer Health Sciences Canada, Inc. |
| Sep 21, 2018 | RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, ... | Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 20, 2018 | AS-OBGYN Information System version 7.824.x | Any change made to current ultrasound machine software or hardware upgrades, adding or modifying ... | Class II | AS Software, Inc. |
| Sep 19, 2018 | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System ... | Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts af... | Class II | Philips Medical Systems Gmbh, DMC |
| Sep 18, 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... | Class I | COVIDIEN LLC |
| Sep 18, 2018 | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 | If an operator attempts to manually program a Basic Infusion for a drug that is not included in t... | Class II | Baxter Healthcare Corporation |
| Sep 17, 2018 | Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... | O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and... | Class II | Medtronic Navigation, Inc.-Littleton |
| Sep 17, 2018 | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc... | Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The comp... | Class II | Beckman Coulter Inc. |
| Sep 13, 2018 | Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#:... | The service manual was not updated at the time of the release of software version 1.30. | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 10, 2018 | Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Sci... | There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber sti... | Class II | Boston Scientific Corporation |
| Sep 4, 2018 | Neuro Omega System, incorporating HaGuide software. For neurological and n... | If cables are improperly connected, current may reach high charge density, causing tissue harm. | Class I | Alpha Omega Engineering |
| Sep 4, 2018 | Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... | Software Correction: Software errors that may result in incorrect 4D CT images, PET images with S... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
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.