Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 550

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

Medical DeviceJun 28, 2023

CRHF ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1 recall — FDA Z-1725-2023

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 DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ recall — FDA Z-1770-2023

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

Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX recall — FDA Z-1988-2023

Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially…

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceJun 28, 2023

CRHF ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1 recall — FDA Z-1803-2023

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

Illumina NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service recall — FDA Z-1976-2023

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Class IIFDA: CompletedIllumina, Inc.

Medical DeviceJun 28, 2023

CRHF ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4 recall — FDA Z-1804-2023

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 XT DR MRI IS1 DF4, Model Number DDPA2D4 recall — FDA Z-1723-2023

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 DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1 recall — FDA Z-1763-2023

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 XT DR MRI IS1 DF1, Model Number DDPA2D1 recall — FDA Z-1721-2023

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 DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1 recall — FDA Z-1771-2023

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 DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1 recall — FDA Z-1745-2023

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 DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1 recall — FDA Z-1713-2023

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 DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1 recall — FDA Z-1795-2023

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 DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4 recall — FDA Z-1772-2023

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

KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA recall — FDA Z-1981-2023

Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray…

Class IIFDA: OngoingKarl Storz Endoscopy

Medical DeviceJun 28, 2023

CRHF CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4 recall — FDA Z-1731-2023

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 MRI IS1 DF4, Model Number DTPB2D4 recall — FDA Z-1782-2023

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 MRI IS1 DF1, Model Number DTPB2D1 recall — FDA Z-1781-2023

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 VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG recall — FDA Z-1734-2023

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 DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4 recall — FDA Z-1796-2023

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 DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1 recall — FDA Z-1767-2023

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 DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1 recall — FDA Z-1807-2023

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 DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1 recall — FDA Z-1799-2023

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 DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4 recall — FDA Z-1714-2023

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)

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