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
Jun 2, 2017	Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P...	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 6663, 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.
Apr 28, 2017	Monica Novii Wireless Patch System product Usage: Novii Interface - The N...	Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged cha...	Class II	MONICA HEALTHCARE LTD
Apr 28, 2017	TI Transport Monitor/Module Battery Pack Product Usage: intended for moni...	Mindray has received two reports from outside the United States that the battery pack for TI tran...	Class II	Mindray DS USA, Inc. dba Mindray North America
Apr 11, 2017	PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT...	Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.	Class II	Sorin Group Italia SRL - CRF
Apr 11, 2017	INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250...	Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.	Class II	Sorin Group Italia SRL - CRF
Apr 11, 2017	OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625...	Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.	Class II	Sorin Group Italia SRL - CRF
Feb 27, 2017	Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ON...	A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 ma...	Class II	Welch Allyn Inc
Feb 24, 2017	HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536...	HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a si...	Class I	Philips North America, LLC
Feb 15, 2017	Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Caps...	When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was d...	Class II	IntroMedic Co., Ltd.
Feb 8, 2017	Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous...	Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting dow...	Class II	Del Mar Reynolds Medical, Ltd.
Jan 31, 2017	MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel...	Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro...	Class II	Medtronic Inc.
Dec 30, 2016	Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ...	Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,...	Class II	Hospira Inc., A Pfizer Company
Dec 23, 2016	CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09...	Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CAR...	Class II	Maquet Datascope Corp - Cardiac Assist Division
Nov 1, 2016	Alaris System PC unit, model no. 8000 and 8015. The central programming, mon...	Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef...	Class II	CareFusion 303, Inc.
Oct 25, 2016	SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Ca...	Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to th...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 19, 2016	Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile ...	Products are not designed, qualified, manufactured, and/or managed under a state of control per i...	Class II	Ultroid Technologies, Inc.
Oct 10, 2016	Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241...	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio...	Class I	St Jude Medical Inc.
Oct 10, 2016	Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad...	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio...	Class I	St Jude Medical Inc.
Oct 10, 2016	Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C...	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio...	Class I	St Jude Medical Inc.
Oct 3, 2016	Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h...	Medtronic has identified an increased number of complaints from customers involving reports of Re...	Class II	Medtronic Neuromodulation
Aug 12, 2016	Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo...	78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016	Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product...	78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Jul 18, 2016	NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X...	Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ...	Class II	Aribex Inc
Jul 18, 2016	NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged...	Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ...	Class II	Aribex Inc
Jun 24, 2016	Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:...	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
Jun 24, 2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
May 5, 2016	Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Powe...	Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either t...	Class II	Stryker Medical Division of Stryker Corporation
May 3, 2016	Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Mod...	Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior ...	Class II	Medtronic Neuromodulation
Apr 13, 2016	Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor...	Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ...	Class I	Medtronic
Apr 6, 2016	EZ Slide Battery/line powered hydraulic table with removable leg section and ...	The potential exists within the identified tables that incorrectly manufactured parts have been u...	Class II	Skytron, Div. The KMW Group, Inc
Feb 25, 2016	TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high...	The firm received a complaint of the battery exploding while recharging.	Class II	Scottcare Corporation
Feb 23, 2016	Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E...	Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC...	Class II	Medtronic Inc.
Feb 12, 2016	Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092	CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca...	Class II	CareFusion 303, Inc.
Feb 4, 2016	Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.	The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C...	Class I	Draeger Medical, Inc.
Jan 15, 2016	Universal Battery Charger II (UBC II)	The device is reported to enter safe mode and is no longer able to charge batteries.	Class II	The Anspach Effort, Inc.
Jan 13, 2016	Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily...	Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.	Class II	Resmed Corporation
Jan 7, 2016	HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ...	Heartware Ventricular Assist System Battery Cell experiencing premature depletion.	Class I	Heartware, Inc.
Dec 23, 2015	Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ...	The sterile battery may contain particulates within the sterile package.	Class II	Pro-Dex Inc
Dec 23, 2015	Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ...	The sterile battery may contain particulates within the sterile package.	Class II	Pro-Dex Inc
Dec 21, 2015	Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Dens...	A possible malfunction where a Short-term Battery Error message has appeared and has been traced ...	Class II	Fukuda Denshi USA, Inc.
Dec 1, 2015	Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN...	The firm became aware of cases in which the battery run times of the optional PS 500 power supply...	Class I	Draeger Medical, Inc.
Nov 25, 2015	Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp...	Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R...	Class II	The Anspach Effort, Inc.
Nov 18, 2015	Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106	Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb...	Class II	Cyberonics, Inc
Nov 10, 2015	MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The Med...	A small number of specific pumps may trigger a low battery alarm at the beginning of the implante...	Class II	Codman & Shurtleff, Inc.
Nov 10, 2015	Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trig...	The firm identified a malfunction which made it possible for a handpiece to start by itself when ...	Class II	Zimmer, Inc.
Nov 10, 2015	MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The Med...	A small number of specific pumps may trigger a low battery alarm at the beginning of the implante...	Class II	Codman & Shurtleff, Inc.
Nov 10, 2015	Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trig...	The firm identified a malfunction which made it possible for a handpiece to start by itself when ...	Class II	Zimmer, Inc.
Nov 9, 2015	Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The pr...	The product may contain electronic components that lead to a premature drainage of the internal c...	Class II	C.R. Bard, Inc.
Nov 9, 2015	Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat...	Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte...	Class II	Medtronic 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.