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

7801–7825 of 27393

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-1745-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic's implantable cardioverter defibrillators may produce reduced or no energy during high voltage therapy due to a feedthrough defect. A total of 1,076 units are affected worldwide.
Product
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; 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-1757-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
3,570 implantable cardioverter defibrillators and cardiac resynchronization defibrillators with a specific feedthrough defect may fail to deliver high-voltage therapy when needed.
Product
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1793-2023·2023-06-28
Implantable Defibrillators May Produce Reduced or No Energy Output
Medtronic implantable cardioverter defibrillators may produce reduced or no-energy output during high voltage therapy due to a defective feedthrough component. The defect affects 176 units distributed worldwide.
Product
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1727-2023·2023-06-28
Implantable cardioverter defibrillators may output reduced or no energy during therapy
Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.
Product
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1786-2023·2023-06-28
Implantable Defibrillators Risk Reduced Energy Output During Therapy
Medtronic implantable defibrillators with a specific feedthrough may fail to deliver adequate energy during high voltage therapy. Approximately 476 affected units distributed nationwide and worldwide.
Product
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1760-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators (ICDs and CRT-Ds) may fail to deliver critical therapy due to a manufacturing defect in the feedthrough. This rare issue affects 23,223 devices.
Product
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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-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-1761-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Energy During Therapy
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy devices may fail to deliver adequate energy during high voltage therapy due to a feedthrough component defect. The rare condition could prevent the device from functioning when needed.
Product
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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-1705-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
Product
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1819-2023·2023-06-28
Implantable defibrillators may fail to deliver high-voltage therapy during treatment
Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.
Product
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1783-2023·2023-06-28
Implantable Defibrillator Models May Fail to Deliver Shock Therapy
Medtronic implantable cardiac defibrillators may fail to deliver electrical therapy during treatment due to a defective feedthrough component. Approximately 1,878 devices are affected.
Product
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1709-2023·2023-06-28
Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Certain Medtronic ICDs manufactured with a specific feedthrough may fail to deliver high-voltage therapy. Patients should contact their healthcare provider immediately.
Product
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1710-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.
Product
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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-1800-2023·2023-06-28
Medtronic implantable defibrillators recalled for potential therapy delivery failure
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
Product
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1781-2023·2023-06-28
Implantable Cardiac Devices Risk Therapy Failure From Feedthrough Defect
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.
Product
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1804-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Failure to Deliver Therapy
Medtronic implantable cardioverter defibrillators with a specific feedthrough defect may rarely fail to deliver high-voltage therapy. Approximately 34,350 devices distributed worldwide are affected.
Product
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1785-2023·2023-06-28
Medtronic implantable defibrillators recalled for potential therapy delivery failure
Medtronic has recalled certain implantable cardioverter defibrillators due to a rare risk of reduced or no energy output during high-voltage therapy.
Product
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1758-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Therapeutic Shock
Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially failing to deliver life-saving shocks.
Product
CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1802-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.
Product
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1812-2023·2023-06-28
Implantable Defibrillators May Have Reduced Energy Output During Therapy
Medtronic is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may produce reduced or no energy output during high-voltage therapy, potentially preventing treatment delivery.
Product
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide

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7801–7825 of 27393