Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 548

The newest recall records with useful source details are listed here.

Medical DeviceJun 28, 2023

HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor recall — FDA Z-1993-2023

Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by…

Class IIFDA: OngoingHeartware, Inc.

Medical DeviceJun 28, 2023

Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1 recall — FDA Z-1992-2023

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

Class IIFDA: OngoingDraeger Medical Systems, Inc.

Medical DeviceJun 28, 2023

CRHF CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ recall — FDA Z-1756-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4 recall — FDA Z-1766-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4 recall — FDA Z-1710-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1 recall — FDA Z-1791-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4 recall — FDA Z-1806-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4 recall — FDA Z-1801-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1 recall — FDA Z-1711-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

Wilson-Cook Medical Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF recall — FDA Z-1979-2023

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability…

Class IIFDA: OngoingWilson-Cook Medical Inc.

Medical DeviceJun 28, 2023

CRHF ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1 recall — FDA Z-1709-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G recall — FDA Z-1724-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4 recall — FDA Z-1792-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

Helena Laboratories Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the recall — FDA Z-1975-2023

Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the…

Class IIFDA: OngoingHelena Laboratories, Corp.

Medical DeviceJun 28, 2023

SenTec AG V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System recall — FDA Z-1980-2023

The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

Class IIFDA: OngoingSenTec AG

Medical DeviceJun 28, 2023

CRHF CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G recall — FDA Z-1730-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ recall — FDA Z-1784-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1 recall — FDA Z-1738-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4 recall — FDA Z-1750-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1 recall — FDA Z-1761-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4 recall — FDA Z-1726-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ recall — FDA Z-1733-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

CRHF ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1 recall — FDA Z-1810-2023

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Class IFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medical DeviceJun 28, 2023

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 recall — FDA Z-1984-2023

TC-I tip clip sensor may produce readings outside the accuracy specification.

Class IIFDA: OngoingMasimo Corporation

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