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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 355

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

Medical DeviceJun 28, 2023

CRHF CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4 recall — FDA Z-1750-2023

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 DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1 recall — FDA Z-1738-2023

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 DF4, Model Number DTPB2QQ recall — FDA Z-1784-2023

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 DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G recall — FDA Z-1730-2023

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

SenTec AG V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System recall — FDA Z-1980-2023

The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

Class IIFDA: OngoingSenTec AG

Medical DeviceJun 28, 2023

Helena Laboratories Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the recall — FDA Z-1975-2023

Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the…

Class IIFDA: OngoingHelena Laboratories, Corp.

Medical DeviceJun 28, 2023

CRHF ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4 recall — FDA Z-1792-2023

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 DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G recall — FDA Z-1724-2023

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 DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1 recall — FDA Z-1709-2023

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

Wilson-Cook Medical Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF recall — FDA Z-1979-2023

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability…

Class IIFDA: OngoingWilson-Cook Medical Inc.

Medical DeviceJun 28, 2023

CRHF ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1 recall — FDA Z-1711-2023

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 DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4 recall — FDA Z-1801-2023

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 XT OUS DF4, Model Number DVFB2D4 recall — FDA Z-1806-2023

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 XT OUS IS1/DF1, Model Number DVAB2D1 recall — FDA Z-1791-2023

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 DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4 recall — FDA Z-1710-2023

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 DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4 recall — FDA Z-1766-2023

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 DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ recall — FDA Z-1756-2023

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

Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1 recall — FDA Z-1992-2023

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

Class IIFDA: OngoingDraeger Medical Systems, Inc.

Medical DeviceJun 28, 2023

HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor recall — FDA Z-1993-2023

Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by…

Class IIFDA: OngoingHeartware, Inc.

Medical DeviceJun 28, 2023

CRHF CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ recall — FDA Z-1779-2023

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 230CM 5/BX recall — FDA Z-1990-2023

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 DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ recall — FDA Z-1764-2023

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 DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4 recall — FDA Z-1813-2023

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 DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1 recall — FDA Z-1743-2023

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.