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.

10751–10775 of 53043

  • HighFDA (Devices)·Z-0447-2024·2023-12-13

    Medical Radiation Therapy System Detector Arm Malfunction Poses Uncontrolled Extension Risk

    Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.

    Product
    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0468-2024·2023-12-13

    EVO VISIAN intraocular lens recalled for potential specification non-compliance

    Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.

    Product
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0440-2024·2023-12-13

    Automated Impella Controller Software Issue Prevents Pump Detection

    Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.

    Product
    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
    Category
    Medical Device
    Distribution
    5 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 (Food)·F-0496-2024·2023-12-13

    BAPS Shayona Burfi Sweetened Ricotta Fudge Recalled for Undeclared Soy

    BAPS Shayona burfi (sweetened ricotta fudge) is recalled due to undeclared soy allergen. The product was distributed to AL, FL, GA, NC, SC, and TN.

    Product
    BAPS SHAYONA Burfi Sweetened ricotta fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53037 Contains: Milk
    Category
    Food
    Distribution
    6 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-0465-2024·2023-12-13

    FDA Class II Recall: Intraocular Lens Implants May Not Meet Specifications

    Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighNHTSA·23V840000·2023-12-13

    2021-2023 Porsche Taycan Battery Short Circuit Fire Risk

    Porsche is recalling 2021-2023 Taycan models due to a potential short circuit in the high-voltage battery that increases the risk of fire. Owners should contact Porsche customer service at 1-800-767-7243 for free inspection and repair.

    Product
    PORSCHE — PORSCHE TAYCAN 4 CROSS TURISMO, TAYCAN GTS SPORT TURISMO, TAYCAN, TAYCAN TURBO S CROSS TURI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2024·2023-12-13

    Injectable ceFAZolin Sodium Recalled for Lack of Sterility Assurance

    Wells Pharma is recalling 825 syringes of injectable ceFAZolin sodium distributed in Philadelphia, Pennsylvania, due to lack of assurance that the product meets required sterility standards.

    Product
    ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0443-2024·2023-12-13

    Medical Radiation Therapy System Potential Detector Arm Malfunction Due to Microswitch Issue

    Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.

    Product
    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0431-2024·2023-12-13

    ProCuity Bed Series Recalled for Electrical Safety Test Failures

    Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0492-2024·2023-12-13

    Coconut Fudge Recalled Due to Undeclared Soy Allergen

    BAPS Shayona is recalling Kopra Paak Coconut Fudge (12 oz, code A06D2023) for undeclared soy, a major allergen. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Kopra Paak Coconut fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53119 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0490-2024·2023-12-13

    BAPS Shayona sweet rolls recalled for undeclared artificial food dyes

    BAPS Shayona Kaju Pista Roll sweet rolls are being recalled because they contain undeclared Yellow #5, Yellow #6, and Blue 1 food dyes. The recall affects 138 units distributed to six southern states.

    Product
    BAPS SHAYONA Kaju Pista Roll Sweet rolls made from cashew and pistachio filling Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53068 Contains: Nuts
    Category
    Food
    Distribution
    6 states
  • 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-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
    1 state
  • 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-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-0498-2024·2023-12-13

    Integra Cranial Access Kit recalled due to packaging defect

    Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2024·2023-12-13

    ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

    Stryker's ProCuity bed series (model 3009) is being recalled due to missing electrical safety test documentation. The beds present a potential risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2024·2023-12-13

    Vyaire Flexible Patient Circuits 3100A Distributed Without U.S. Approval

    Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.

    Product
    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0510-2024·2023-12-13

    VITROS ECO2 Chemistry Slides may produce inaccurate CO2 test results

    Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.

    Product
    VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2024·2023-12-13

    EVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure

    Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0508-2024·2023-12-13

    DJO EMPOWR Knee System Recall: Incorrect Device in Packaging

    Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.

    Product
    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2024·2023-12-13

    CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction

    CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.

    Product
    CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
    Category
    Medical Device
    Distribution
    15 states