Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA1D1 CLARIA MRI US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA1D4 CLARIA MRI US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA1Q1 CLARIA MRI QUAD US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA1QQ CLARIA MRI QUAD US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA2D1 CLARIA MRI OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA2D4 CLARIA MRI OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB1D1 AMPLIA MRI US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB1D4 AMPLIA MRI US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB1QQ AMPLIA MRI QUAD US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB2D1 AMPLIA MRI OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB2D4 AMPLIA MRI OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMC1D1 COMPIA MRI US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMC1QQ COMPIA MRI QUAD US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMC2D1 COMPIA MRI OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMC2D4 COMPIA MRI OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT XT HF MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTPA2D1G COBALT XT HF QUAD OUS There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTPA2D1PX COBALT XT HF QUAD OUS There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT XT HF MRI IS1 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT XT HF QUAD MRI IS4 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT XT HF QUAD MRI IS4 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT XT HF QUAD OUS There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT HF MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT HF MRI IS1 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT HF QUAD MRI IS4 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD COBALT HF QUAD MRI IS4 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD CROME HF MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD CROME HF MRI IS1 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD CROME HF QUAD MRI IS4 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD CROME HF QUAD MRI IS4 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVAB1D1 VISIA AF US IS1/DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVAB1D4 VISIA AF US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR VISIA AF XT OUS IS1/DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR VISIA AF XT OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR VISIA AF S US/OUS IS1/DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR VISIA AF S US/OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVBB1D1 EVERA XT IS1/DF1 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVBB1D4 EVERA XT DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVBB2D4 EVERA XT DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.