The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

16551–16575 of 27263

  • 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-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-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-1818-2023·2023-06-28

    Medtronic ICD COBALT XT Recalled for Potential Energy Output Failure

    Medtronic has recalled certain implantable defibrillators (ICDs) due to a potential for reduced or no-energy output during therapy. Affected devices may fail to deliver required treatment for dangerous heart rhythms.

    Product
    ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; 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-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-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 (Food)·F-0990-2023·2023-06-28

    Miyako Select Shredded Crab Meat recalled for undeclared wheat and eggs

    Aquamar Inc is recalling Miyako Select shredded crab meat and related crab-flavored seafood products due to undeclared wheat and eggs allergens. The recall affects approximately 31,079 cases distributed across the United States and Canada.

    Product
    Miyako Select Shredded Crab Meat Keep Refrigerated #1485 Ingredients: Fish Protein (Pollock, Threadfin Bream and/or Flying Fish), Water, Potato Starch, Modified Food Starch, Contains less than 2% of the following: Sugar, Salt, Sorbitol, Carrageenan, Natural and Artificial Flavors
    Category
    Food
    Distribution
    12 states
  • 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-1737-2023·2023-06-28

    Medtronic Implantable Heart Defibrillators Risk Therapy Delivery Failure

    Medtronic CRT-D and ICD implantable defibrillators may fail to deliver therapy due to a rare defect in a specific feedthrough component. The recalled devices carry a potential for reduced or no-energy output during high-voltage heart rhythm treatment.

    Product
    CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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-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-1820-2023·2023-06-28

    ICD Cobalt VR MRI Implantable Defibrillators Recall Due to Potential Therapy Failure

    Medtronic is recalling 1,930 ICD Cobalt VR MRI implantable defibrillators due to a rare risk of reduced or no-energy output during high voltage therapy. The defect affects units with a specific glassed feedthrough component.

    Product
    ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; 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-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-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-1728-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.

    Product
    ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1751-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.

    Product
    CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; 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-1815-2023·2023-06-28

    Implantable Defibrillators With Defective Feedthrough May Fail During Critical Therapy

    Medtronic is recalling 14,270 implantable cardioverter defibrillators with a specific feedthrough that may produce reduced or no energy output during high-voltage therapy. The affected devices may fail to deliver critical treatment when needed.

    Product
    ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; 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 (Drugs)·D-0893-2023·2023-06-28

    Prescription Drug Recall: Ziprasidone Cartons Contain Wrong Medication

    Unit Dose cartons labeled as Ziprasidone Hydrochloride 20 mg were found to contain Dronabinol 2.5 mg instead. Lot T04769 (Exp. 2024/12) was distributed nationwide.

    Product
    ZIPRASIDONE — ZIPRASIDONE (ZIPRASIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1720-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy

    Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected worldwide.

    Product
    ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide