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Browse Device Recalls

160 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 160 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 160 FDA device recalls.

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DateProductReasonClassFirm
Jun 17, 2015 Invivo Expression MRI Patient Monitoring System. The device's labeling inaccurately indicates Endotracheal as a body temperature application site.... Class II Philips Electronics North America Corporation
Jun 5, 2015 Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStar... Multiple software and hardware issues with device that can affect its function. Class II Philips Electronics North America Corporation
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
Mar 23, 2015 Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems w... The system is designed to emit a beep upon termination of an exposure. However, if the system has... Class II Philips Electronics North America Corporation
Nov 19, 2014 ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside ... When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor... Class II Philips Electronics North America Corporation
Jul 31, 2014 Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 45356044604... Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 ... Class II Philips Electronics North America Corporation
Dec 17, 2010 M3150 Information Center Local Database; Models: 862249, 865001, 865003, 8650... Potential for early component failure. Class II Philips Electronics North America Corporation

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.