The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13301–13325 of 22165

  • HighFDA (Devices)·Z-0448-2024·2023-12-13

    Monarch Platform bronchoscope recalled for potential software image inversion

    AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.

    Product
    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Food)·F-0484-2024·2023-12-13

    Dietary supplement recalled for undeclared soy allergen

    Garden of Life RM-10 ULTRA dietary supplement recalled for undeclared soy. Approximately 8,940 bottles were distributed domestically and internationally.

    Product
    Garden of Life, RM-10 ULTRA, Ultimate Immune System Support60 Vegetarian Caplets, Whole Food Dietary Supplement, 90 Ultra Zorbe Vegetarian Capsules
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0454-2024·2023-12-13

    Red Light Therapy Bed Canopy Strut Detachment Risk Nationwide

    Thor Photomedicine is recalling six THOR NOVO GEN 2.0 XL whole body red light therapy beds due to ball stud component failure. The defect causes gas strut detachment, making the canopy difficult to lift.

    Product
    G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2024·2023-12-13

    ProCuity Patient Beds Missing Electrical Safety Tests: Burn and Shock Risk

    Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.

    Product
    ProCuity bed series, model number 3009, item number: 300900000000,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2024·2023-12-13

    Intraocular Lens Implants Recalled for Specification Non-Compliance

    Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0485-2024·2023-12-13

    Atrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process

    Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0492-2024·2023-12-13

    Integra Cranial Access Kit recall due to outer packaging defect

    Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.

    Product
    Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0498-2024·2023-12-13

    Milled Brown Flax Recalled Due to Plastic Contamination Risk

    Scoular Grain Co is recalling 40,000 pounds of Milled Brown Flax (lot REG23268) distributed in Texas and Canada due to plastic foreign object contamination. The product poses a choking and injury hazard if consumed.

    Product
    Milled Brown Flax - MBF9, 50lb bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0456-2024·2023-12-13

    NovoTHOR Gen 2.5 XL Red Light Therapy Bed Canopy Gas Strut Detachment Recall

    Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.

    Product
    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0483-2024·2023-12-13

    Garden of Life Mushroom Supplement Recalled for Undeclared Soy

    Garden of Life RM-10 mushroom supplement recalled due to undeclared soy, a common allergen. The recall affects 15,119 bottles distributed domestically and internationally; consumers with soy allergies should not use these products.

    Product
    Garden of Life, RM-10, Organically Grown Mushrooms, 60 Vegetarian Caplets, Whole Food Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0442-2024·2023-12-13

    Medical Radiation Therapy Device Microswitch May Cause Uncontrolled Detector Arm Extension

    Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.

    Product
    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0488-2024·2023-12-13

    BAPS Shayona Ricotta Fudge Discs Recalled for Undeclared Soy

    BAPS Shayona is recalling 723 units of Plain Penda Ricotta fudge discs because some contain undeclared soy. The product was distributed to six states and poses a risk for those with soy allergies.

    Product
    BAPS SHAYONA Plain Penda Ricotta fudge discs flavored with rose water Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53152 Contains: Milk, Nut
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0446-2024·2023-12-13

    Medical radiation therapy system detector arm extension recall

    Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.

    Product
    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0482-2024·2023-12-13

    Dietary Supplement Recalled for Undeclared Soy Allergen

    Garden of Life FYI ULTRA Joint & Cartilage Formula dietary supplement recalled due to undeclared soy. Consumers with soy allergies should not use affected bottles.

    Product
    Garden of Life, FYI ULTRA, ULTIMATE Joint & Cartilage Formula, Whole Food Dietary Supplement, 120 Ultra Zorbe VEGETARIAN CAPSULES
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0474-2024·2023-12-13

    EVO VISIAN Intraocular Lenses recalled for potential specification defects

    Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.

    Product
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0489-2024·2023-12-13

    BAPS Shayona Kaju Katri Cashew Fudge Recalled for Undeclared Yellow #5 Dye

    BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Kaju Katri Kesar Cashew fudge flavored with saffron Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53065 Contains: Nut
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0438-2024·2023-12-13

    CardioQuip Modular Cooler-Heater heating chamber malfunction poses burn risk

    CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.

    Product
    CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0477-2024·2023-12-13

    HVAD Ventricular Assist Device Updated Instructions for Alarm Conditions

    Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·23V838000·2023-12-12

    Tesla Model Y Autosteer Recall: Software Update for Control Prominence

    Tesla is recalling 2.03 million 2012-2023 Model S/X/3/Y vehicles with Autosteer due to insufficient control prominence that may allow driver misuse and crash risk. A free OTA software update will be provided.

    Product
    TESLA — 2022 TESLA MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V682000·2023-12-10

    2023 Cadillac Lyriq Pedestrian Warning Sounds May Not Activate

    General Motors is recalling certain 2023 Cadillac Lyriq vehicles due to a software defect in the body control module. The pedestrian warning sounds may fail to activate, creating a crash risk.

    Product
    CADILLAC — 2023 CADILLAC LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V681000·2023-12-10

    GMC Acadia and Cadillac Windshield Detachment Risk Recall

    General Motors is recalling 2023 GMC Acadia vehicles and certain 2024 Cadillac models due to windshields that may not be properly bonded to the vehicle body. A detached windshield during a crash could increase the risk of injury.

    Product
    GMC — 2023 GMC ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V680000·2023-12-10

    2023 Toyota 4Runner Load Capacity Label Correction Recall

    Southeast Toyota Distributors is recalling certain 2023 Toyota 4Runner vehicles due to an incorrect load carrying capacity modification label. The error could result in vehicle overloading and increased crash risk.

    Product
    TOYOTA — 2023 TOYOTA 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V477000·2023-12-07

    Jayco Seneca recreational vehicles recalled for windshield wiper linkage failure

    Jayco is recalling certain 2021-2022 Seneca recreational vehicles because the windshield wiper arms may fail, reducing driver visibility and increasing crash risk. Owners should contact Jayco customer service at 1-800-283-8267 for a free inspection and replacement.

    Product
    JAYCO — 2021 JAYCO SENECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24731·2023-12-07

    Moonsea Pack and Play Mattresses Recalled for Suffocation Hazard

    Moonsea Pack and Play Mattresses sold on Amazon violate federal crib mattress safety regulations and pose a suffocation hazard to infants. Consumers should stop using them immediately and contact Moonseasleep for a refund.

    Product
    Moonsea Pack and Play Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24047·2023-12-07

    Windsor Queen Xtrabed Mobile Murphy Beds Recalled for Injury and Tip-Over Hazards

    SourceOne Ventures recalls Windsor Queen Xtrabed Mobile Murphy Beds due to risks of cabinet breakage and tip-over. About 12,000 units sold at Wayfair between November 2016 and April 2023 are affected.

    Product
    Windsor Queen Xtrabed Mobile Murphy Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide