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 2, 2015	Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corp...	The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs hav...	Class II	Invacare Corporation
Jan 9, 2015	The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de...	Current labeling indicates that cycling improves device longevity in every programming scenario. ...	Class II	Medtronic Neuromodulation
Jan 7, 2015	System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a ...	Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a h...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 20, 2014	Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg...	VCG battery ignited in a VCG unit when recharging.	Class II	Philips Medical Systems, Inc.
Nov 19, 2014	Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A	1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitor...	Class II	Philips Medical Systems, Inc.
Oct 29, 2014	Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V...	If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou...	Class II	Respironics California Inc
Oct 17, 2014	Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid...	Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa...	Class II	Maquet Cardiovascular Us Sales, Llc
Oct 7, 2014	Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: Th...	Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Sur...	Class II	Mortara Instrument, Inc
Oct 6, 2014	UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric hand...	Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece ...	Class II	Zimmer Surgical Inc
Sep 29, 2014	Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system ...	It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update...	Class II	Merge Healthcare, Inc.
Sep 25, 2014	ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo ...	The insulin pump may lose time and date settings during a power interruption (such as a battery c...	Class II	Roche Diagnostics Operations, Inc.
Sep 17, 2014	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11...	Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ...	Class II	Boston Scientific CRM Corp
Sep 17, 2014	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat...	Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ...	Class II	Boston Scientific CRM Corp
Sep 17, 2014	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene...	A failure of a specific component may prevent the ventilators from operating on AC power or trans...	Class I	Respironics California Inc
Aug 5, 2014	CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL...	The firm became aware of a potential problem that was initiated by a customer complaint. After c...	Class II	Curbell Medical, Inc.
Jul 28, 2014	Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte...	ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. The...	Class II	ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jul 25, 2014	Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (...	Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its ca...	Class II	Estill Medical Technologies, Inc
Jul 14, 2014	Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S...	Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent...	Class II	Medtronic Neuromodulation
Jun 12, 2014	Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350...	A small number of sealed foil pouches containing the electrodes were found to be difficult to ope...	Class II	Heartsine Technologies, Limited
Jun 11, 2014	Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED...	LED battery chargers may prematurely fail and will not charge the LED battery as intended	Class II	Integra LifeSciences Corp.
May 9, 2014	LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP100...	Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK...	Class II	Physio-Control, Inc.
Apr 29, 2014	Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infan...	The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring...	Class II	Childrens Medical Ventures
Apr 24, 2014	Baxter Amia Automated PD systems are used in the treatment of adult renal fai...	System error 01779 is produced when the battery cannot be charged due to specific voltage differe...	Class II	Baxter Healthcare Corp.
Apr 16, 2014	HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Heart...	Patients and caregivers are instructed that if a battery does not provide two hours of support or...	Class II	HeartWare Inc
Apr 4, 2014	Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor...	The risk of battery failure increases with age, when a battery remains in use longer than 3 years...	Class II	Philips Medical Systems, Inc.
Feb 18, 2014	HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J...	Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experienc...	Class II	Philips Medical Systems, Inc.
Feb 18, 2014	GemStar Docking Station, used with GemStar infusion pump, in combination with...	There are two situations that may occur when using the GemStar Docking Station, List Number 13075...	Class I	Hospira Inc.
Feb 7, 2014	Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care...	The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Crit...	Class I	Draeger Medical Systems, Inc.
Feb 6, 2014	Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ...	Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C...	Class II	Philips Medical Systems North America Inc.
Feb 3, 2014	The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is...	The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one...	Class I	Hospira Inc.
Feb 3, 2014	The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is...	The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one...	Class I	Hospira Inc.
Jan 30, 2014	Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i...	The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, tap...	Class II	Synthes, Inc.
Jan 24, 2014	Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart...	HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp...	Class II	Philips Medical Systems, Inc.
Oct 10, 2013	Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat...	Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell le...	Class II	Nova Biomedical Corporation
Sep 12, 2013	MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf...	It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma...	Class II	Maquet Medical Systems USA
Aug 29, 2013	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat...	The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact...	Class II	Boston Scientific CRM Corp
Aug 29, 2013	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11...	The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact...	Class II	Boston Scientific CRM Corp
Aug 28, 2013	* 1) SYMBIQ One-Channel Infuser; * 2) SYMBIQ Two-Channel Infuser; **...	Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr...	Class II	Hospira Inc.
Jul 16, 2013	ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store ...	The products may have been stored at temperatures outside their required storage conditions.	Class II	Assuramed
Jul 16, 2013	Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (...	Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ...	Class III	Zoll Circulation, Inc.
Jun 4, 2013	ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system t...	Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complem...	Class II	Baxa Corporation
Jun 3, 2013	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ...	Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2...	Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m...	Class I	Medtronic Neuromodulation
May 28, 2013	VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System...	DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlo...	Class II	DJO, LLC
Apr 24, 2013	embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilato...	Calibration error for Embla Embletta Gold units calibrated through service center between June 15...	Class II	Embla System Llc
Apr 10, 2013	Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,...	Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e...	Class II	Philips Medical Systems, Inc.
Apr 5, 2013	Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batterie...	Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instrumen...	Class I	Newport Medical Instruments Inc
Mar 21, 2013	The GemStar Pump is a small and lightweight, single channel infusion device d...	During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica...	Class II	Hospira Inc.
Mar 21, 2013	The GemStar Pump is a small and lightweight, single channel infusion device d...	During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica...	Class II	Hospira Inc.
Mar 18, 2013	GemStar Pump - Battery Product Usage: The GemStar Pump is a small and li...	Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th...	Class I	Hospira 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.