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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

23,306medical device recall records

2,192FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.745 records

Database records

Records — page 352

23,306 detailed records are currently available in this category.

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

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 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

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 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

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 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

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-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

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-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

Karl Storz Endoscopy Metal Tray, 178 x 135 x 37 mm, REF: 11580A recall — FDA Z-1991-2023

Metal 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 models,…

Class IIFDA: OngoingKarl Storz Endoscopy

Medical DeviceJun 28, 2023

Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 165 CM recall — FDA Z-1987-2023

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 CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4 recall — FDA Z-1754-2023

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 DVMD3D1 PRIMO MRI, Model Number DVMD3D1 recall — FDA Z-1814-2023

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 DF4, Model Number DDPC3D4 recall — FDA Z-1728-2023

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 DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4 recall — FDA Z-1705-2023

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 XT HF MRI IS1 DF4, Model Number DTPA2D4 recall — FDA Z-1777-2023

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 DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1 recall — FDA Z-1704-2023

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)

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-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 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 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)

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.