U.S. Recalls in June 2023

June 2023 recalls — page 6

These records include useful source details for the selected month.

2023 archive →

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)

Medical DeviceJun 28, 2023

CRHF ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG recall — FDA Z-1780-2023

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 DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ recall — FDA Z-1752-2023

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 S US/OUS IS1/DF1, Model Number DVAC3D1 recall — FDA Z-1793-2023

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 DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4 recall — FDA Z-1762-2023

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 DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1 recall — FDA Z-1769-2023

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 DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1 recall — FDA Z-1757-2023

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 DF4, Model Number DTPC2D4 recall — FDA Z-1786-2023

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: 2503 recall — FDA Z-1986-2023

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

Class IIFDA: OngoingMasimo Corporation

Medical DeviceJun 28, 2023

CRHF CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1 recall — FDA Z-1732-2023

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 DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ recall — FDA Z-1739-2023

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 DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4 recall — FDA Z-1746-2023

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 DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G recall — FDA Z-1722-2023

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 DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1 recall — FDA Z-1715-2023

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 DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1 recall — FDA Z-1707-2023

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)

FoodJun 28, 2023

ENTRINSIC HEALTH SOLUTION enterade Advanced Oncology Formula recall — FDA F-0999-2023

Potential for the product to develop mold and spoil.

Class IIFDA: TerminatedENTRINSIC HEALTH SOLUTION Inc.

FoodJun 28, 2023

Fire Distributors Plus EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES recall — FDA F-1001-2023

Products contain kratom, an unapproved food additive.

Class IIFDA: TerminatedFire Distributors Plus LLC

FoodJun 28, 2023

Fire Distributors Plus EARTH KRATOM TRAINWRECK 150 CAPSULES recall — FDA F-1000-2023

Products contain kratom, an unapproved food additive.

Class IIFDA: TerminatedFire Distributors Plus LLC

FoodJun 28, 2023

Nutricia TYR Anamix Early Years infant formula Net Wt recall — FDA F-0989-2023

Infant formula contains undeclared tyrosine

Class IIFDA: TerminatedNutricia North America

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.

U.S. Recalls — June 2023

June 2023 recalls — page 6

How to use this monthly recall archive