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

9126–9150 of 13652

SevereFDA (Devices)·Z-1784-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled Due to Potential Therapy Failure
Medtronic is recalling approximately 15,427 implantable cardioverter defibrillators with a specific feedthrough due to a rare potential for reduced or no energy output during high voltage therapy. Patients should contact their healthcare provider.
Product
CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1764-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Therapy in Rare Cases
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may rarely fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough.
Product
CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1756-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic issued a Class I recall for certain implantable cardioverter defibrillators due to a rare risk that high-voltage therapy may not deliver. Affected models include DTMA1QQ devices made with a specific feedthrough component.
Product
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; 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-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-1810-2023·2023-06-28
Implantable cardioverter defibrillators may fail to deliver therapy
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with specific glassed feedthroughs that may deliver reduced or no energy output during high voltage therapy.
Product
ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1741-2023·2023-06-28
Implantable Defibrillator Recall: Risk of Failed High-Voltage Therapy
Medtronic implantable defibrillators may fail to deliver therapy due to a defective feedthrough component. 207 units recalled nationwide and worldwide.
Product
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; 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-1723-2023·2023-06-28
ICD COBALT XT Defibrillators Recalled for Potential Reduced Energy Output
Medtronic recalled 22,114 ICD COBALT XT defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy delivery caused by a specific feedthrough defect.
Product
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1768-2023·2023-06-28
Medtronic Implantable Defibrillators Risk Failure to Deliver High-Voltage Therapy
Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific feedthrough may fail to deliver high-voltage therapy. The FDA is recalling 28,172 units as a Class I safety issue.
Product
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1797-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Reduced Energy Output
Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.
Product
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1775-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillator Model DTPA2D1G Therapy Output Failure
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation therapy.
Product
CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; 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-1770-2023·2023-06-28
Cardioverter Defibrillators Recalled: Potential Reduced or No-Energy Output
Certain Medtronic implantable cardioverter defibrillators may fail to deliver proper energy output during high-voltage therapy due to a feedthrough defect. Patients with affected devices should contact Medtronic immediately.
Product
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1795-2023·2023-06-28
Implantable Defibrillators May Deliver Reduced or No Energy During Therapy
Certain Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high voltage therapy. The rare defect affects 16 units distributed nationwide.
Product
ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1814-2023·2023-06-28
Medtronic ICD-VR PRIMO MRI Defibrillators: Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators and CRT-Ds may fail to deliver adequate energy during high-voltage therapy due to a feedthrough component defect. This affects 5,215 units distributed worldwide.
Product
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1771-2023·2023-06-28
Medtronic implantable defibrillators may fail to deliver therapy
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.
Product
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1747-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 7 implantable cardioverter-defibrillators that may fail to deliver electrical therapy during critical heart rhythms. The defect affects devices with a specific feedthrough component.
Product
CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; 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-1776-2023·2023-06-28
Medtronic Implantable Defibrillators May Fail Therapy Energy Delivery
Medtronic recalls 3 COBALT XT implantable defibrillators that may deliver reduced or no energy during therapy. A defect in the device feedthrough could prevent effective treatment of abnormal heart rhythms.
Product
CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; 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-1715-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.
Product
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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-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-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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9126–9150 of 13652