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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,000 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,000 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 1,000 FDA device recalls.

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DateProductReasonClassFirm
Jun 26, 2012 GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... Class I GE Healthcare, LLC
Jun 15, 2012 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety ri... Class II Ge Healthcare It
Jun 13, 2012 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monit... GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. The... Class II GE Healthcare, LLC
Jun 13, 2012 GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking st... GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor.... Class II GE Healthcare, LLC
Jun 12, 2012 GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 201... GE Healthcare has become aware through complaints of a potential safety issue with its Invasive B... Class II GE Healthcare, LLC
Jun 8, 2012 GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without ... GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod... Class II GE Healthcare, LLC
Jun 8, 2012 GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnos... GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod... Class II GE Healthcare, LLC
Jun 8, 2012 GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR ... GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod... Class II GE Healthcare, LLC
May 29, 2012 Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... Class II GE Healthcare, LLC
May 25, 2012 GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Vie... Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safe... Class II GE Healthcare, LLC
May 24, 2012 GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advanta... GE Healthcare has become aware of an issue associated with the magnification images acquired on n... Class II GE Healthcare, LLC
May 24, 2012 GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.... GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol o... Class II GE Healthcare, LLC
May 24, 2012 AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 516009... It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, t... Class II GE Healthcare, LLC
May 24, 2012 GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 an... GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdv... Class II GE Healthcare, LLC
May 24, 2012 GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View... GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT... Class II GE Healthcare, LLC
Apr 23, 2012 GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Produ... GE Healthcare has recently become aware of a potential issue due to image flip in frequency encod... Class II GE Healthcare, LLC
Apr 19, 2012 The GE Centricity Web; Software Version 3.0x, is intended for use under the d... GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco... Class II Ge Healthcare It
Apr 10, 2012 GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-O... GE Healthcare has recently become aware of a potential safety issue due to the interlock slide me... Class I GE Healthcare, LLC
Apr 4, 2012 GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (A... GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... Class II GE Healthcare, LLC
Mar 27, 2012 GE Healthcare, Advantage Workstation, READY View Application. Image analys... GE Healthcare has become aware that when analyzing fMRI images using the READY View application s... Class II GE Healthcare, LLC
Mar 6, 2012 GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Op... Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomogra... Class II GE Healthcare, LLC
Feb 20, 2012 enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW D... The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 109... Class II Vital Signs Devices, a GE Healthcare Company
Feb 17, 2012 GE Healthcare Carescape Patient Data Module with v2.0 software used with Sola... GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software ... Class II GE Healthcare, LLC
Jan 23, 2012 VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139;... GE Healthcare has become aware of an issue associated with the base casting for the articulated a... Class II GE Healthcare, LLC
Jan 4, 2012 GE Healthcare Muse v7 cardiology information system. Model number 2026443-00... GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on ... Class II GE Healthcare, LLC
Dec 20, 2011 GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ,... While performing a fluoroscopic examination on the GE Innova systems, there is a potential of non... Class II GE Healthcare, LLC
Dec 20, 2011 GE Healthcare innova 3100, Mobile X-ray system. The innova systems are in... It was discovered of a potential failure of the spectral filter mechanism inside the collimator o... Class II GE Healthcare, LLC
Dec 20, 2011 GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are ... It was discovered of a potential failure of the spectral filter mechanism inside the collimator o... Class II GE Healthcare, LLC
Dec 20, 2011 GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are i... It was discovered of a potential failure of the spectral filter mechanism inside the collimator o... Class II GE Healthcare, LLC
Nov 21, 2011 SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWIN... Screen save images are included in wrong exam due to duplicate UID creation. This may cause a saf... Class II GE Healthcare, LLC
Oct 28, 2011 Fusion Workstation.; Indicated for the transmission and review of radiologica... After a period of time running Fusion Workstation, the Hounsfield measurement tool will report in... Class II Merge Healthcare, Inc.
Oct 21, 2011 GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascula... As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover... Class II GE Healthcare, LLC
Oct 19, 2011 CADstream software Product Usage: CADstream is an image processing syst... Customers may experience an issue with the software study preferences when changes are made to th... Class II Merge Healthcare, Inc.
Oct 6, 2011 GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, pro... GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used ... Class II GE Healthcare, LLC
Sep 30, 2011 GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul... GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. ... Class II GE Healthcare, LLC
Jul 25, 2011 GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lights... Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can... Class II GE Healthcare, LLC
Jul 20, 2011 GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas ... GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 wh... Class II GE Healthcare, LLC
May 16, 2011 GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscop... GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes dur... Class II GE Healthcare, LLC
May 10, 2011 Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa... An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved ... Class II GE Healthcare, LLC
Apr 5, 2011 GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ra... GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1... Class II GE Healthcare, LLC
Mar 25, 2011 GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW Volu... When performing a secondary capture generated from GSI Viewer, the header information is correct ... Class II GE Healthcare, LLC
Mar 4, 2011 Imagecast PACS is an image management system intended to be used by trained p... In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was... Class II Ge Healthcare It
Feb 4, 2011 GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular... Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of ... Class II GE Healthcare, LLC
Jun 22, 2009 OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); I... GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated... Class I GE OEC Medical Systems, Inc
Oct 19, 2007 GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt ... X-ray units did not meet manufacturer's specification for linearity. Class II GE OEC Medical Systems, Inc
Nov 8, 2006 The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is... GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insert... Class II GE OEC Medical Systems, Inc
Oct 11, 2006 OEC InstaTrak 3500, picture archiving and communications system intended as a... GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to ... Class II GE OEC Medical Systems, Inc
Sep 15, 2006 InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
May 31, 2006 GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3... An incident was reported that an operator's finger was pinched between the fixed roller and the g... Class II General Electric Med Systems LLC
May 31, 2006 GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha... An incident was reported that an operator's finger was pinched between the fixed roller and the g... Class II General Electric Med Systems LLC

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.