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 84

Records are ordered by the best available source date.

Medical DeviceJun 28, 2023

CRHF ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4 recall — FDA Z-1794-2023

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 QUAD MRI IS4 DF1, Model Number DTPC2Q1 recall — FDA Z-1787-2023

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 DDMD3D1 PRIMO MRI, Model Number DDMD3D1 recall — FDA Z-1717-2023

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 LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 recall — FDA Z-1985-2023

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

Class IIFDA: OngoingMasimo Corporation

Medical DeviceJun 28, 2023

CRHF ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4 recall — FDA Z-1798-2023

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 DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1 recall — FDA Z-1797-2023

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 DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4 recall — FDA Z-1811-2023

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 RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 recall — FDA Z-1983-2023

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

Class IIFDA: OngoingMasimo Corporation

Medical DeviceJun 28, 2023

CRHF CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1 recall — FDA Z-1755-2023

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 DDME3D4 MIRRO MRI, Model Number DDME3D4 recall — FDA Z-1720-2023

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 DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4 recall — FDA Z-1809-2023

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

MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 recall — FDA Z-1982-2023

Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure…

Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield

Medical DeviceJun 28, 2023

CRHF CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1 recall — FDA Z-1749-2023

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 DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4 recall — FDA Z-1800-2023

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 DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ recall — FDA Z-1744-2023

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 MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) recall — FDA Z-1977-2023

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Class IIFDA: CompletedIllumina, Inc.

Medical DeviceJun 28, 2023

CRHF ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4 recall — FDA Z-1718-2023

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 S US/OUS DF4, Model Number DVFC3D4 recall — FDA Z-1808-2023

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 DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1 recall — FDA Z-1805-2023

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 DVME3D4 MIRRO MRI, Model Number DVME3D4 recall — FDA Z-1817-2023

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 DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ recall — FDA Z-1773-2023

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 DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1 recall — FDA Z-1729-2023

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 VR MRI IS1 DF1, Model Number DVPC3D1 recall — FDA Z-1822-2023

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 DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4 recall — FDA Z-1708-2023

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 84

About the 2023 recall archive