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
Aug 14, 2018	Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC...	The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact wit...	Class II	Ohio Medical Corporation
Jul 26, 2018	Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Prod...	Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Moni...	Class II	Covidien LLC
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
Jul 2, 2018	Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The devic...	Charging base may overheat with localized melting and sparking, possibly causing fire, shock or b...	Class II	Water Pik, Inc.
Jun 21, 2018	Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 9, 2018	ImagePilot, Model No. D9MA	Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignit...	Class II	Konica Minolta Medical Imaging USA, Inc.
May 9, 2018	CS-7, Model No. A4C1	Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignit...	Class II	Konica Minolta Medical Imaging USA, Inc.
May 2, 2018	Heartware Medtronic HVAD System for cardiac use. Including the following pa...	Possible transient electrical connection interruption between an HVAD System power source (Batter...	Class I	Heartware
Apr 23, 2018	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4...	The fuel gauge, the component that reads and reports the battery parameters to the pump, could pr...	Class II	Tandem Diabetes Care Inc
Apr 16, 2018	Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650...	The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai...	Class II	St Jude Medical Inc.
Apr 16, 2018	St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: ...	The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai...	Class II	St Jude Medical Inc.
Apr 13, 2018	Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca...	Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.	Class II	St Jude Medical, Cardiac Rhythm Management Divi...
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Mar 12, 2018	Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adul...	After two and a half years, the battery fuel gauge may indicate a higher battery charge than what...	Class II	Hamilton Medical AG
Mar 12, 2018	Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adul...	After two and a half years, the battery fuel gauge may indicate a higher battery charge than what...	Class II	Hamilton Medical AG
Feb 7, 2018	Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. End...	Device may display a battery missing error.	Class II	Medela Inc
Feb 2, 2018	3M Surgical Clipper Professional 9681	Failure to follow proper charging practices can result in lithium-ion battery degradation, charac...	Class II	3M Company - Health Care Business
Dec 14, 2017	Dynavox T15 Speech Generating Device ( including Batteries)	The battery is integral to the device. If the device sits unused and is not charged for a length...	Class II	Dynavox Systems Llc
Dec 14, 2017	Dynavox T10 Speech Generating Device ( including Batteries)	The battery is integral to the device. If the device sits unused and is not charged for a length...	Class II	Dynavox Systems Llc
Nov 29, 2017	BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 92065...	Some printing modes on the devices may not function properly (tabular data printing, real-time co...	Class II	Smiths Medical ASD Inc.
Nov 21, 2017	Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilato...	Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Benne...	Class II	Covidien LLC
Nov 13, 2017	VNS Therapy Programmer, Model 3000, v1.0 System	Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo...	Class II	Cyberonics, Inc
Oct 30, 2017	Plum 360 Infusion System, List number 30010.	(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" sta...	Class II	ICU Medical Inc
Oct 16, 2017	Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ...	For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices...	Class II	Fukuda Denshi Co., Ltd.
Sep 12, 2017	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable...	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 12, 2017	Proclaim DRG Implantable Pulse Generator Model 3664	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 12, 2017	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener...	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Aug 28, 2017	Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ...	The device may exhibit premature battery depletion.	Class I	St Jude Medical Inc.
Aug 28, 2017	Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu...	The device may exhibit premature battery depletion.	Class I	St Jude Medical Inc.
Jul 14, 2017	TD60 Transmitter battery charger used with the BeneVision Central Station, Pa...	A damaged circuit board in the battery charger can cause the battery to overcharge and the batter...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 7, 2017	Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery...	The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective ...	Class II	Ondamed Inc
Jun 12, 2017	Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo...	Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte...	Class II	Roche Diabetes Care, Inc.
Jun 12, 2017	Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G...	Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte...	Class II	Roche Diabetes Care, Inc.
Jun 2, 2017	Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, 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.