Browse Device Recalls

88 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 88 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 88 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 7, 2022	The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providi...	Update to instructions for use regarding the cleaning and disinfection process for the reusable p...	Class II	Philips North America, LLC
Mar 23, 2021	Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for moni...	Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of h...	Class II	Philips North America, LLC
Nov 19, 2020	Emission Computed Tomography System Image Process System - Product Usage: int...	A software defect that has the potential to result in image misdiagnosis and incorrect treatment ...	Class II	Philips North America, LLC
Sep 14, 2020	Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Mode...	The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator...	Class II	Philips North America, LLC
Sep 14, 2020	Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model ...	The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator...	Class II	Philips North America, LLC
Jul 16, 2020	Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M35...	The therapy switch may fail, resulting in the device exhibiting the following behaviors: the devi...	Class II	Philips North America, LLC
Jun 30, 2020	IntelliVue MX700 patient monitor, model no. 865241	Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de...	Class II	Philips North America, LLC
Jun 30, 2020	IntelliVue MX800 patient monitor, model no. 865240	Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de...	Class II	Philips North America, LLC
Jun 25, 2020	IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.1...	The device may experience an interruption of gas measurement due to a firmware issue, ceasing mea...	Class II	Philips North America, LLC
Jun 18, 2020	Phillips Charging Station, Product #: 989803191021 - Product Usage: This char...	A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a...	Class II	Philips North America, LLC
Jun 18, 2020	Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Prod...	A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a...	Class II	Philips North America, LLC
Jun 18, 2020	Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module...	A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a...	Class II	Philips North America, LLC
Jun 8, 2020	Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lnte...	Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867...	Class II	Philips North America, LLC
Jun 2, 2020	EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagn...	Thermo switches in the main power supply for the system may be incorrectly installed, resulting i...	Class II	Philips North America, LLC
May 19, 2020	Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The Su...	Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that ...	Class II	Philips North America, LLC
Apr 27, 2020	Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A,...	HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv...	Class II	Philips North America, LLC
Apr 23, 2020	ProxiDiagnost N90, UDI 706100	The thermo switches in the three-phase transformer, which normally aid in powering down the Syste...	Class II	Philips North America, LLC
Apr 21, 2020	Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product ...	HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv...	Class II	Philips North America, LLC
Apr 20, 2020	Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an...	Internal Paddles may wear over time and may not be safe or ready for use, unless the directions i...	Class II	Philips North America, LLC
Apr 13, 2020	Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumog...	The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr...	Class II	Philips North America, LLC
Apr 13, 2020	Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The c...	The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr...	Class II	Philips North America, LLC
Apr 13, 2020	Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product U...	The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1...	Class II	Philips North America, LLC
Apr 10, 2020	Philips Zenition 50, System code 718096 - Product Usage: The devices are used...	When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor...	Class II	Philips North America, LLC
Apr 10, 2020	HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a componen...	Damaged ESD bags used for storing components in Processor PCA Replacement Kits	Class II	Philips North America, LLC
Apr 10, 2020	Philips Zenition 70, System code 718133 - Product Usage: The devices are used...	When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor...	Class II	Philips North America, LLC
Apr 7, 2020	Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 72001...	If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.	Class II	Philips North America, LLC
Apr 6, 2020	Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model ...	The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips...	Class II	Philips North America, LLC
Apr 6, 2020	Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI ...	The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips...	Class II	Philips North America, LLC
Apr 6, 2020	Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311	The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips...	Class II	Philips North America, LLC
Apr 3, 2020	Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1...	When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and...	Class II	Philips North America, LLC
Mar 5, 2020	Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidan...	No torque was specified for the four screws that connect the gearbox and the mounting flange with...	Class II	Philips North America, LLC
Mar 5, 2020	TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service N...	The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran...	Class II	Philips North America, LLC
Mar 5, 2020	TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System ...	The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran...	Class II	Philips North America, LLC
Feb 26, 2020	HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M353...	Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffe...	Class II	Philips North America, LLC
Feb 20, 2020	Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa...	Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incor...	Class II	Philips North America, LLC
Jan 14, 2020	Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips H...	M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid ...	Class II	Philips North America, LLC
Jan 13, 2020	Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th...	if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde...	Class II	Philips North America, LLC
Dec 30, 2019	Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 ...	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	Allura CV20, system code 722031	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	Poly G Integris H5000, System code 72246	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708...	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system c...	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	OmniDiagnost Eleva System codes 708028 708027	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	UroDiagnost Eleva, system code 708033	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	Cardio Vascular-Allura Centron, system code 722400	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 30, 2019	Integris Allura 9, system codes 722018 722021	A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s...	Class II	Philips North America, LLC
Dec 23, 2019	VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft...	Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselN...	Class II	Philips North America, LLC
Nov 20, 2019	ProxiDiagnost N90	Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.	Class II	Philips North America, LLC
Oct 16, 2019	HeartStart XL+ Defibrillator/Monitor, Model 861290	The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behav...	Class II	Philips North America, LLC
Oct 3, 2019	HeartStart XL+ Defibrillator/Monitor, Model 861290	Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a...	Class II	Philips North America, 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.