Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7776–7800 of 27393

SevereFDA (Devices)·Z-1787-2023·2023-06-28
Medtronic Implantable Defibrillators Risk Failing to Deliver Electrical Therapy
Medtronic is recalling 404 units of implantable cardioverter defibrillators and cardiac resynchronization devices due to a rare risk of reduced or absent energy output during therapy. The defect involves a specific manufacturing feedthrough component.
Product
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1706-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Failure During High-Voltage Treatment
Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.
Product
ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1762-2023·2023-06-28
Medtronic Cardiac Defibrillators Potentially Fail to Deliver High-Voltage Therapy
Medtronic's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may fail to deliver high-voltage therapy due to a defect in specific glassed feedthrough components. The FDA classified this as a Class I recall due to potential for serious harm.
Product
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1811-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Therapy Due to Feedthrough Defect
Medtronic's ICD-VR DVMB2D4 implantable defibrillators may fail to deliver electrical therapy due to a defect in the feedthrough component. The recall affects 6,477 units distributed worldwide.
Product
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1798-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail To Deliver Therapy; Class I Recall
Medtronic implantable cardioverter defibrillators (ICDs) may fail to deliver high-voltage therapy due to a manufacturing defect in a specific feedthrough component. 447 units are affected worldwide.
Product
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1765-2023·2023-06-28
Implantable Defibrillators Recalled: Potential Therapy Energy Delivery Failure
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.
Product
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1792-2023·2023-06-28
Medtronic ICD defibrillators may fail to deliver critical therapy
Medtronic recalled certain implantable defibrillators that may fail to deliver electrical therapy during critical heart rhythm events due to a manufacturing defect in the device feedthrough.
Product
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1774-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.
Product
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1766-2023·2023-06-28
Implantable defibrillators may deliver reduced or no energy during therapy
Medtronic implantable defibrillators and cardiac resynchronization devices with a specific glassed feedthrough may fail to deliver full energy during therapy. Approximately 8,575 units affected worldwide.
Product
CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1746-2023·2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
Medtronic is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.
Product
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1714-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output
Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.
Product
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1796-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
Medtronic recalls implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.
Product
ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1748-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Therapy During Critical Events
Certain Medtronic implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough manufacturing defect. 523 units distributed worldwide are affected.
Product
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1809-2023·2023-06-28
Medtronic Implantable Defibrillators May Fail to Deliver High-Voltage Therapy
Medtronic implantable defibrillators with a specific feedthrough defect may rarely experience reduced or no-energy output during high-voltage therapy. Patients should contact their healthcare provider for evaluation.
Product
ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1716-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to a rare potential for reduced or no energy output during high voltage therapy. Approximately 37,547 units are affected.
Product
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1704-2023·2023-06-28
Implantable defibrillators may fail to deliver high-voltage therapy due to defect
Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.
Product
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1801-2023·2023-06-28
Medtronic implantable cardioverter defibrillators recalled for potential reduced-output defect
Medtronic has recalled certain ICD and CRT-D cardiac devices due to a rare risk of reduced or no energy output during high-voltage therapy. The affected models contain a specific glassed feedthrough component.
Product
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1803-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
Medtronic implantable cardioverter defibrillators (ICDs) with a specific feedthrough component may have reduced or absent energy output during high voltage therapy. The FDA Class I recall affects 12,099 units distributed nationwide and worldwide.
Product
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1759-2023·2023-06-28
Implantable Cardiac Defibrillators May Fail During High-Voltage Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
Product
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1779-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Critical Heart Therapy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy delivery due to a defective feedthrough component. No injuries have been reported, but patients may not receive proper treatment for life-threatening heart rhythms.
Product
CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1749-2023·2023-06-28
Implantable Cardiac Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Certain Medtronic implantable cardiac defibrillators with specific glassed feedthrough components may deliver reduced energy during high-voltage therapy. This could prevent the device from functioning when needed in cardiac emergencies.
Product
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1753-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver High-Voltage Therapy Energy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.
Product
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1778-2023·2023-06-28
Implantable Defibrillators May Deliver Reduced Energy During Therapy
Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected in the US and worldwide.
Product
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1752-2023·2023-06-28
Medtronic CRT-D BRAVA Implantable Defibrillators—Potential High-Voltage Therapy Failure
Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.
Product
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1826-2023·2023-06-28
ARROW Endurance Peripheral Catheters Recalled for Separation and Leakage Risk
ARROW Endurance Extended Dwell Peripheral Catheters are being recalled due to potential catheter separation or leakage. The recall affects 262,016 units distributed nationwide and in Canada.
Product
ARROW Endurance Extended Dwell Peripheral Catheter System
Category
Medical Device
Distribution
Distributed nationwide

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7776–7800 of 27393