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

926–950 of 1396

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-1794-2023·2023-06-28
FDA Recalls Medtronic Implantable Defibrillators Due to Potential Output Risk
Medtronic's ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.
Product
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-1744-2023·2023-06-28
Medtronic CRT-D Defibrillators Recalled for Potential Therapy Output Failure
Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.
Product
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; 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-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-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-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-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-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-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-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-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-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-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-1822-2023·2023-06-28
Implantable Heart Defibrillators May Fail to Deliver Therapy
Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.
Product
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; 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-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-1807-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
Medtronic recalls approximately 5,622 implantable cardioverter defibrillators that may produce reduced or no energy output during high-voltage therapy due to a specific feedthrough component defect.
Product
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1726-2023·2023-06-28
Medtronic ICD COBALT DR Potential Reduced Energy Output During Therapy
Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.
Product
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; 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-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-1808-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail During High Voltage Therapy
Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a defect in the electrical feedthrough. The devices risk reduced or no energy output during high-voltage treatment.
Product
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide

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