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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.

23,781medical device recall records

2,201FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.751 records

Database records

Records — page 356

23,781 detailed records are currently available in this category.

Medical DeviceJun 28, 2023

CRHF ICD COBALT VR MRI DF4, Model Number DVPB3D4 recall — FDA Z-1821-2023

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 DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX recall — FDA Z-1776-2023

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 DF1, Model Number DTPA2D1 recall — FDA Z-1774-2023

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 EVERA XT DR GOLD CTD, Model Number DDBB1D4G recall — FDA Z-1706-2023

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 DF4, Model Number DVPC3D4 recall — FDA Z-1823-2023

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 VR MRI DF4, Model Number DVPA2D4 recall — FDA Z-1819-2023

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 DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1 recall — FDA Z-1751-2023

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 DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1 recall — FDA Z-1789-2023

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 DF4, Model Number DTPC2QQ recall — FDA Z-1788-2023

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 DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4 recall — FDA Z-1790-2023

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-7, REF recall — FDA Z-1978-2023

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 DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4 recall — FDA Z-1712-2023

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 VR MRI IS1 DF1, Model Number DVPB3D1 recall — FDA Z-1820-2023

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 DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G recall — FDA Z-1775-2023

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 DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1 recall — FDA Z-1747-2023

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 DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4 recall — FDA Z-1737-2023

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 21, 2023

Galt Medical Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 recall — FDA Z-1968-2023

Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the…

Class IIFDA: OngoingGalt Medical Corporation

Medical DeviceJun 21, 2023

Apothecary Products Eye and Ear Dropper, Product Code 67082 recall — FDA Z-1702-2023

Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

Class IIFDA: OngoingApothecary Products, LLC

Medical DeviceJun 21, 2023

Remote Diagnostic Technologies Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 recall — FDA Z-1825-2023

Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message…

Class IIFDA: OngoingRemote Diagnostic Technologies Ltd.

Medical DeviceJun 21, 2023

Merit Medical Systems Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509 recall — FDA Z-1915-2023

There is a potential that valve assemblies will not open. preventing fluid from draining.

Class IIFDA: OngoingMerit Medical Systems, Inc.

Medical DeviceJun 21, 2023

LumiraDx SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample recall — FDA Z-1970-2023

Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical…

Class IIFDA: OngoingLumiraDx

Medical DeviceJun 21, 2023

Merit Medical Systems Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE recall — FDA Z-1917-2023

There is a potential that valve assemblies will not open. preventing fluid from draining.

Class IIFDA: OngoingMerit Medical Systems, Inc.

Medical DeviceJun 21, 2023

Galt Medical Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12 recall — FDA Z-1969-2023

Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the…

Class IIFDA: OngoingGalt Medical Corporation

Medical DeviceJun 21, 2023

Apothecary Products Medicine Dropper, Product Code K508 recall — FDA Z-1703-2023

Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

Class IIFDA: OngoingApothecary Products, LLC

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.