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Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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 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
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

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.