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Browse Device Recalls

65 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 65 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 65 FDA device recalls.

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DateProductReasonClassFirm
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A,... MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M... A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with ... When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart M... Wireless Link may be unable to transmit data when configured for a specific data flow. Class II Philips Medical Systems, Inc.
Feb 14, 2014 Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Produc... Philips HeartStart XL may experience a power board failure causing failure to defibrillate Class II Philips Medical Systems, Inc.
Feb 4, 2014 Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M... HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing... Class II Philips Medical Systems, Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
Dec 10, 2013 Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T... MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev... Class II Philips Medical Systems, Inc.
Dec 5, 2013 Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 ... X-ray system C-arm casting may loosen and fall Class II Philips Medical Systems, Inc.
Oct 30, 2013 Easy Diagnost Eleva Universal Fluoroscopic applications The delivered application software was an outdated version to the model of equipment. Class II Philips Medical Systems, Inc.
Oct 23, 2013 BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the ti... Class II Philips Medical Systems, Inc.
Oct 14, 2013 Philips Multi Diagnost Eleva with FlatDetector The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... Class II Philips Medical Systems, Inc.
Oct 14, 2013 Philips Multi Diagnost Eleva II The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... Class II Philips Medical Systems, Inc.
Jun 7, 2013 Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A2... Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monit... Class II Philips Medical Systems, Inc.
Apr 10, 2013 Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... Class II Philips Medical Systems, Inc.

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.