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

9051–9075 of 13652

CriticalFDA (Devices)·Z-1719-2023·2023-06-28
Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk
Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.
Product
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1742-2023·2023-06-28
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
Product
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1738-2023·2023-06-28
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy
Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.
Product
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1725-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.
Product
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1755-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.
Product
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1739-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Energy Output Failure
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.
Product
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1805-2023·2023-06-28
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.
Product
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1789-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic implantable defibrillators with certain feedthroughs may fail to deliver high-voltage therapy when needed. This rare malfunction could prevent life-saving electrical treatment.
Product
ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1791-2023·2023-06-28
Implantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component affecting 71 units.
Product
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1724-2023·2023-06-28
Medtronic ICD Devices Potential Energy Output Failure During Therapy
Medtronic's implantable cardioverter defibrillators (ICDs) may produce reduced or no energy output during high voltage therapy due to a feedthrough defect. Patients with affected lot numbers should contact their healthcare provider.
Product
ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1707-2023·2023-06-28
Implantable Defibrillators Risk Reduced or No Energy Output During Therapy
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.
Product
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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-1730-2023·2023-06-28
Implantable defibrillators may fail to deliver emergency therapy
Medtronic is recalling CRT-D defibrillators that may fail to deliver electrical therapy during life-threatening heart rhythms due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
Product
CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1772-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough design issue. This could prevent life-saving electrical therapy from being delivered.
Product
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; 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-1740-2023·2023-06-28
Implantable Defibrillators Risk Loss of Therapy from Feedthrough Defect
Medtronic recalls certain CRT-D VIVA QUAD XT GOLD implantable defibrillators due to a rare risk of reduced or no electrical output during therapy. Affected devices contain a specific glassed feedthrough component.
Product
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; 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-1773-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Critical Therapy
Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy delivery. Affected devices were manufactured with a specific feedthrough component.
Product
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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-1713-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may experience reduced or no energy output during high-voltage therapy, potentially preventing treatment of life-threatening heart rhythms.
Product
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1717-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced or No Therapy Output
Certain Medtronic implantable cardioverter defibrillators and cardiac resynchronization defibrillators may fail to deliver energy during high-voltage therapy due to a specific feedthrough design issue. The recall affects 3,801 units distributed in the US and worldwide.
Product
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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-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-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-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

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9051–9075 of 13652