Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 15, 2023	HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positi...	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ...	Class I	Hamilton Medical, Inc.
Jun 15, 2023	The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35...	A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ...	Class I	Baxter Healthcare Corporation
Jun 15, 2023	HAMILTON C2 Ventilator Is intended to provide positive pressure ventilator...	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ...	Class I	Hamilton Medical, Inc.
Jun 15, 2023	HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended t...	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ...	Class I	Hamilton Medical, Inc.
Jun 15, 2023	HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressur...	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ...	Class I	Hamilton Medical, Inc.
Jun 14, 2023	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01...	Devices with Option CP2 and initially programmed to software version P.01.01 were configured inco...	Class II	Philips North America Llc
Jun 7, 2023	BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are a...	Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS D...	Class II	PTW-FREIBURG
Jun 6, 2023	Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbe...	A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that conn...	Class II	Murata Vios, Inc.
Jun 2, 2023	Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1...	A software defect in the DxA Automation System may cause tests to be run on patient samples in tu...	Class II	Beckman Coulter Biomedical GmbH
Jun 2, 2023	Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240...	A software defect in the DxA Automation System may cause tests to be run on patient samples in tu...	Class II	Beckman Coulter Biomedical GmbH
May 30, 2023	Alinity ci-series System Control Module, REF: 03R70-01	There are potential performance issues found in the Alinity ci-series System software versions 3....	Class II	Abbott Laboratories
May 23, 2023	wDR 2.2 Mobile Digital Diagnostic X-Ray System	There is a software login in issue that may prevent the user from logging in.	Class II	SEDECAL SA
May 22, 2023	BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI...	Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen...	Class II	CareFusion 303, Inc.
May 19, 2023	DigitalDiagnost C90, Model No. 712034 and 712035	There is a software login in issue that may prevent the user from logging in.	Class II	Philips North America Llc
May 16, 2023	Aptio Automation Storage and Retrieval Module (SRM)	A firmware error may lead to an incorrect association of test result(s) to a sample ID and theref...	Class II	Siemens Healthcare Diagnostics, Inc.
May 10, 2023	LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004	Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-S...	Class II	Fresenius Kabi USA, LLC
May 5, 2023	bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent...	Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell...	Class II	Vyaire Medical
May 5, 2023	bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven...	Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell...	Class II	Vyaire Medical
May 4, 2023	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080...	The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc...	Class III	Datascope Corp.
May 2, 2023	V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring Syste...	The sensors may experience an out-of-box failure because after recalibration, the sensors stayed ...	Class II	SenTec AG
Apr 25, 2023	FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-011...	The firm has identified an increased risk of obtaining false positive Cryptosporidium results fro...	Class II	BioFire Diagnostics, LLC
Apr 19, 2023	Patient Information Center iX, Product Code 866386, and Patient Information C...	During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto...	Class II	Philips North America
Apr 12, 2023	Ultraview SL (UVSL) Command Module, Model 91496	Command modules will display the following when parameter processing is suspended, depending on s...	Class II	Spacelabs Healthcare, Inc.
Apr 11, 2023	StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/...	In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ...	Class I	Medtronic Navigation, Inc.
Apr 11, 2023	StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit...	During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau...	Class I	Medtronic Navigation, Inc.
Apr 5, 2023	Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia...	The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ...	Class II	Draeger Medical Systems, Inc.
Apr 5, 2023	BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E...	Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in...	Class II	CareFusion 303, Inc.
Apr 5, 2023	Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls...	The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ...	Class II	Draeger Medical Systems, Inc.
Apr 5, 2023	BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ...	Due to an automated dispensing cabinet software issue, when a medication single order contains mo...	Class II	CareFusion 303, Inc.
Apr 5, 2023	NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic...	Cybersecurity vulnerability concerning the software used for sequencing instruments.	Class II	Illumina, Inc.
Apr 5, 2023	MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS...	Cybersecurity vulnerability concerning the software used for sequencing instruments.	Class II	Illumina, Inc.
Mar 27, 2023	TDHisto/Cyto - A software product used for managing medical information in th...	In a specific use case, when printing labels for slides, some labels may display wrong information	Class II	Technidata S.A.
Mar 22, 2023	BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 a...	Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A...	Class II	Becton Dickinson & Co.
Mar 21, 2023	Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2....	Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 14, 2023	HAMILTON-C6, REF: 160021	Software error causes, safety ventilation, in which ventilation continues in the "safety ventilat...	Class II	Hamilton Medical AG
Mar 10, 2023	Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names ...	Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ...	Class II	Inpeco S.A.
Mar 10, 2023	PVT Interface Module (PVT)-Laboratory Automation system Brand names of the...	Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ...	Class II	Inpeco S.A.
Mar 10, 2023	Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand...	Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ...	Class II	Inpeco S.A.
Mar 10, 2023	Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names...	Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ...	Class II	Inpeco S.A.
Mar 10, 2023	Storage and Retrieval Module (SRM)-Laboratory Automation system Brand name...	Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ...	Class II	Inpeco S.A.
Mar 8, 2023	AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The...	Due to potential software issue that may result in patient mix-up information.	Class II	Radiometer Medical ApS
Mar 6, 2023	EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr...	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r...	Class II	Philips North America Llc
Mar 6, 2023	EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ...	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r...	Class II	Philips North America Llc
Mar 1, 2023	Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE...	Due to a software issue where the process of patient scanning, the scatter correction may occasio...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Feb 27, 2023	RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device fo...	There is the potential for the program software to malfunction which will not allow it to move fo...	Class II	Appliedvr
Feb 17, 2023	Raystation treatment planning system for radiation therapy, Model Numbers 9.0...	It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle wil...	Class II	RAYSEARCH LABORATORIES AB
Feb 14, 2023	Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therap...	Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a stand...	Class II	Brainlab AG
Feb 10, 2023	Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software...	When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may de...	Class II	Sensus Healthcare, Inc.
Feb 2, 2023	LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Sof...	Under specific circumstances, the U.S. product registration system did not send up enablement req...	Class II	Boston Scientific Corporation
Jan 25, 2023	Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L ...	Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output...	Class II	Stryker 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.