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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
Nov 15, 2018 Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1... There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plott... Class II Philips Electronics North America Corporation
Oct 10, 2018 IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - ... A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affec... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurova... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovasc... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascu... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurov... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascula... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovas... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular ... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurov... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neur... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular ... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurova... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular ... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurova... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovasc... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neuro... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascula... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurov... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 86... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns V... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central m... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
May 3, 2018 HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (8612... The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may... Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Mar 16, 2018 ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic devi... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/P... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 78148... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnos... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic devi... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems M... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: In... Potential risk for helium gas inside the MR examination room during a magnet quench 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.