2023 U.S. Recalls — FDA & NHTSA Archive

Monthly breakdown

2023 recalls by month

Select a month to review the recall records reported during that period.

2023 recalls — page 82

Records are ordered by the best available source date.

Medical DeviceJun 28, 2023

Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 230 CM recall — FDA Z-1989-2023

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 DVME3D1 MIRRO MRI, Model Number DVME3D1 recall — FDA Z-1816-2023

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 DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G recall — FDA Z-1736-2023

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 DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1 recall — FDA Z-1735-2023

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 DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1 recall — FDA Z-1741-2023

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 DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4 recall — FDA Z-1742-2023

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 DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4 recall — FDA Z-1802-2023

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 DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1 recall — FDA Z-1812-2023

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 DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1 recall — FDA Z-1765-2023

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 DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1 recall — FDA Z-1753-2023

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 DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4 recall — FDA Z-1758-2023

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 DF1, Model Number DTPB2Q1 recall — FDA Z-1783-2023

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 VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG recall — FDA Z-1740-2023

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 DVMD3D4 PRIMO MRI, Model Number DVMD3D4 recall — FDA Z-1815-2023

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 CROME DR MRI IS1 DF1, Model Number DDPC3D1 recall — FDA Z-1727-2023

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 CROME HF MRI IS1 DF1, Model Number DTPC2D1 recall — FDA Z-1785-2023

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 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)

About the 2023 recall archive

This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.

U.S. Recalls in 2023

2023 recalls by month

2023 recalls — page 82

About the 2023 recall archive