Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 14, 2020 MR Coils The MR Coil is intended to be used in conjunction with a Magnetic... The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protect... Class III Invivo Corporation
Feb 6, 2020 Monitor for the Functional Imaging System for Magnetic Resonance Imaging System Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. Class II Invivo Corporation
Sep 24, 2018 Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo... Class II Invivo Corporation
Aug 3, 2018 Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Versio... Released with an incorrect, older firmware version installed. May result in intermittent loss of... Class II Invivo Corporation
Mar 14, 2018 PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 45356424190... The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Di... Class II Invivo Corporation
Jan 24, 2018 DynaCad software consist of an MR Analysis Server software and the viewer wor... Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not... Class II Invivo Corporation
Nov 20, 2017 Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonito... While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Win... Class II Invivo Corporation
Aug 18, 2017 Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive inve... Intermittent communication between the host system and the FlexCardio Class II Invivo Corporation
Aug 11, 2017 Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitor... Intermittent communication between the host system and the Flex Cardio Class II Invivo Corporation
May 6, 2016 Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Chan... A diode was inadvertently not assembled into the system, which may result in coil overheating Class II Invivo Corporation
Oct 19, 2015 The system provides the ability to transmit patient data files for storage, v... Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze Class II Invivo Corporation
Oct 22, 2014 Philips Expression MR200 MRI Patient Monitoring System. The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; po... Class II Invivo Corporation
Sep 14, 2014 Philips Expression Information Portal (IP5) Model 865471. The IP5 is intend... Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notificati... Class II Invivo Corporation
Sep 8, 2014 Philips Expression MR200 MRI Patient Monitoring System Model 866120 During production, excess metal (aluminum) debris was found stuck to the cling plastic that cover... Class II Invivo Corporation
Sep 5, 2014 Philips Expression MR200 MRI Patient Monitoring System Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. Class II Invivo Corporation
Jun 30, 2014 Philips IP5 Information Portal The Expression Information Portal (Model IP... The wireless function of the IP5 radio could be interrupted causing loss of wireless communicatio... Class II Invivo Corporation
Dec 4, 2013 Invivo Corporation Expression Information Portal (Model IP5) is intended to b... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expressi... Class II Invivo Corporation
Oct 3, 2013 Invivo Corporation Expression IP5 Information Portal Product Usage: T... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expres... Class II Invivo Corporation
Oct 15, 2012 Invivo Corporation Expression MRI Patient Monitoring System. The Expressio... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expressi... Class II Invivo 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.