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Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

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DateProductReasonClassFirm
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.