Browse Device Recalls

723 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 723 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 723 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 4, 2020	CareFusion Alaris Pump Module, Model 8100	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Feb 4, 2020	CareFusion Alaris PCA Module, Model 8120	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Feb 4, 2020	CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038...	1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i...	Class I	CareFusion 303, Inc.
Jan 23, 2020	HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica...	Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA...	Class I	Heartware, Inc.
Jan 23, 2020	HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System...	Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA...	Class I	Heartware, Inc.
Jan 22, 2020	Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. S...	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ...	Class II	Braemar Manufacturing, LLC
Jan 22, 2020	Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. S...	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ...	Class II	Braemar Manufacturing, 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 12, 2019	ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150	Combination of software and a component failure may cause audible alarms not to operate properly,...	Class I	ResMed Ltd.
Dec 2, 2019	Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with...	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Dec 2, 2019	PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, ...	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Dec 2, 2019	Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Dec 2, 2019	PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, w...	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Nov 4, 2019	Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of ...	The indicator may show available charge when the battery is close to depletion. As a result, the ...	Class II	Becton Dickinson & Company
Oct 28, 2019	Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei...	There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ...	Class I	Smiths Medical ASD Inc.
Sep 26, 2019	TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002	Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I...	Class III	Theralase Inc.
Sep 16, 2019	SAROS Oxygen System Model 3000	There is an electronics control issue that causes the unit to not power on with battery power only.	Class II	Caire, Inc.
Aug 21, 2019	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a...	Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)...	Class II	Boston Scientific Corporation
Aug 21, 2019	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a...	Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)...	Class II	Boston Scientific Corporation
Jun 28, 2019	Workstation, G2, Configured (P/N 000-0241)	Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the...	Class II	Intellijoint Surgical, Inc.
Jun 24, 2019	TAPSYSTEM Model 2A, REF 8002A	There is a potential for an assembly error resulting in the battery wire being connected to the O...	Class III	Cardiocommand Inc.
Jun 17, 2019	Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card...	If battery maintenance is not performed appropriately, the battery may provide less than the mini...	Class I	Datascope Corp.
Jun 17, 2019	CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova...	If battery maintenance is not performed per instructions, the battery may provide less than the m...	Class I	Datascope Corp.
Jun 17, 2019	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card...	Battery short-run times and unanticipated stoppage may be due to user not performing battery main...	Class I	Datascope Corp.
Jun 17, 2019	CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova...	If battery maintenance is not performed per instructions, the battery may provide less than the m...	Class I	Datascope Corp.
Jun 17, 2019	CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova...	If battery maintenance is not performed appropriately, the battery may provide less than the mini...	Class I	Datascope Corp.
Jun 17, 2019	CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova...	If battery maintenance is not performed appropriately, the battery may provide less than the mini...	Class I	Datascope Corp.
Jun 7, 2019	Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535...	The AC power module may fail at a higher than expected rate. If a fully charged battery is not p...	Class II	Philips North America, LLC
May 20, 2019	Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used...	Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o...	Class II	Medtronic Inc.
May 10, 2019	CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode...	Possible corrosion of the battery contact(s).	Class III	Cardiocommand Inc.
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: ...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: ...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Mar 28, 2019	IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All ...	The MX40 may experience increased power consumption and may have a lack of visual and/or audible ...	Class II	Philips North America, LLC
Dec 18, 2018	Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)	Product was packaged with the Incorrect tamper proof battery door.	Class II	Cochlear Americas Inc.
Nov 23, 2018	HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which...	Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should...	Class II	Philips North America LLC
Nov 19, 2018	Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600...	HVAD Battery Charger units manufactured with wrong inductors.	Class II	Heartware, Inc.
Nov 16, 2018	Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir...	This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device...	Class II	LivaNova USA Inc
Nov 16, 2018	Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi...	This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device...	Class II	LivaNova USA Inc
Nov 16, 2018	The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons...	Lead impedance values reported by the affected VNS generator will be higher compared to those rep...	Class II	LivaNova USA Inc
Nov 1, 2018	The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov...	Experienced accelerated battery depletion and a shortened replacement interval due to latent inte...	Class II	Boston Scientific Corporation
Oct 15, 2018	Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, ...	There is a potential for the male connectors on external cables to become damaged. This could inc...	Class II	Jarvik Heart Inc
Sep 25, 2018	PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S...	Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s...	Class II	Pro-Dex Inc
Sep 10, 2018	VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	ESSENTIO Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	ACCOLADE Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	PROPONENT Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Aug 31, 2018	Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batterie...	The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) batt...	Class II	Widex A/S
Aug 27, 2018	Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage...	The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete s...	Class II	Arthrex, 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.