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.

16576–16600 of 27263

  • 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-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-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-1721-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver High Voltage Therapy

    Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high voltage therapy due to a defective feedthrough. This defect could prevent the device from properly treating life-threatening heart rhythms.

    Product
    ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; 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-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-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-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-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-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-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-1817-2023·2023-06-28

    Implantable Cardiac Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic's ICD-VR DVME3D4 defibrillators are recalled due to a rare risk of reduced or no energy output during high-voltage therapy. The defect involves a specific feedthrough component and affects approximately 14,989 units distributed nationwide and worldwide.

    Product
    ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1003-2023·2023-06-28

    Frozen Waffles Recalled: Undeclared Soy Lecithin Allergen Risk

    Julian's Recipe Maple & Brown Butter Cauli-Wafels are being recalled due to undeclared soy lecithin. The product poses a risk to consumers with soy allergies.

    Product
    Julian's Recipe Maple & Brown Butter Cauli-Wafels, 7.41 oz.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0989-2023·2023-06-28

    TYR Anamix Early Years infant formula recalled for undeclared tyrosine

    Nutricia North America is recalling TYR Anamix Early Years infant formula due to undeclared tyrosine. The recall affects 94 cans distributed to 22 states and Puerto Rico.

    Product
    TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1718-2023·2023-06-28

    Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy

    Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.

    Product
    ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2023·2023-06-28

    Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk

    Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.

    Product
    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2023·2023-06-28

    Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings

    Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.

    Product
    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1981-2023·2023-06-28

    KARL STORZ sterilization trays recalled for inadequate model-specific instructions

    FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.

    Product
    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2023·2023-06-28

    Masimo LNOP TC-I Pulse Oximeter Sensor May Produce Inaccurate Readings

    Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.

    Product
    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1763-2023·2023-06-28

    Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure

    Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.

    Product
    CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2023·2023-06-28

    NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability

    Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.

    Product
    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure

    Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.

    Product
    ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0998-2023·2023-06-28

    Wegmans Penne Rigate Mozzarella Salad recalled for undeclared milk allergen

    Wegmans Penne Rigate Mozzarella Salad is being recalled due to undeclared milk allergen. Affected products were distributed to stores in New York, Pennsylvania, and Massachusetts.

    Product
    Wegmans Penne Rigate Mozzarella Salad Net Wt 30 OZ (1 LB 14 OZ) 850 g. Packaged in a plastic container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0999-2023·2023-06-28

    Medical Food Product Recalled for Potential Mold Contamination

    enterade Advanced Oncology Formula is recalled due to potential mold development and spoilage. The recall affects 43,336 bottles distributed nationwide.

    Product
    enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after ope
    Category
    Food
    Distribution
    47 states