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.

19851–19875 of 50413

  • HighNHTSA·21V550000·2021-07-21

    2020-2021 Bentley Continental GT Front Seat May Trap Rear Passenger Legs

    Bentley is recalling certain 2020-2021 Continental GT vehicles because the front seat may trap a rear passenger's legs during automated movements. The front seat software will be updated free of charge.

    Product
    BENTLEY — BENTLEY CONTINENTAL GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2057-2021·2021-07-21

    GE Healthcare SIGNA PET/MR button mix-up causes image orientation errors

    GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.

    Product
    SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2052-2021·2021-07-21

    MRI scanner user interface defect may cause incorrectly oriented images

    GE Healthcare recalls SIGNA Premier MRI scanners (100 devices, worldwide distribution) due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of Save RX, potentially resulting in incorrectly annotated or flipped diagnostic images.

    Product
    SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0781-2021·2021-07-21

    Living Free Nerve & Muscle Plus Supplement Recalled for Undeclared Soy

    Bea Lydeckers Naturals Inc is recalling Living Free Nerve & Muscle Plus Cetyl-Myristoleate supplement because the label declares lecithin but does not declare that the lecithin is soy-derived, posing a risk to consumers with soy allergies.

    Product
    Living Free Nerve & Muscle Plus Cetyl-Myristoleate Herbal and Glandular Supplement, 180 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Plus Cetyl-Myristoleate…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2021·2021-07-21

    HeartWare HVAD Pump Implant Kit Impeller Defect Recall

    HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.

    Product
    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2025-2021·2021-07-21

    Shoulder prosthesis component distributed with incorrect thickness due to lot swap

    Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.

    Product
    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·21V543000·2021-07-20

    Newell P50 Recalled for Window Adhesive Failure Risk

    Newell Coach Corp. is recalling 2008-2022 P50 vehicles because window vent adhesive may fail, causing the vent to detach and increasing crash risk.

    Product
    NEWELL — NEWELL P50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V546000·2021-07-20

    2022 Kenworth Medium-Duty Trucks Windshield Defrost Failure Recall

    Certain 2022 Kenworth T680, T880, and W990 trucks have defective HVAC controls that may fail to operate the windshield defrost system, reducing driver visibility and increasing crash risk. PACCAR is replacing the HVAC control heads free of charge.

    Product
    KENWORTH — KENWORTH T880, W900, T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V542000·2021-07-20

    2021 Newmar Ventana motorhomes recalled for loose tie rod clamps

    Newmar Corporation is recalling certain 2021 Ventana motorhomes because tie rod clamps may be loose, potentially causing tie rod ends to break or detach and resulting in steering loss.

    Product
    NEWMAR — NEWMAR KOUNTRY STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V547000·2021-07-20

    School Bus Parking Brake May Fail, Increasing Crash Risk

    Daimler Trucks is recalling 267 school buses because the parking brake activation switch may fail to set the parking brake, increasing the risk of unintended vehicle movement and crashes.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V544000·2021-07-20

    Osage Super Warrior Recall for Display Lockup Hazard

    Osage Industries is recalling one 2021 Super Warrior vehicle because the emergency lighting display may lock up, potentially delaying emergency efforts.

    Product
    OSAGE — OSAGE SUPER WARRIOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V545000·2021-07-20

    2022 Tiffin Phaeton motorhomes recalled for fuel hose fire risk

    Tiffin is recalling 2021-2022 Phaeton and Allegro Bus motorhomes with certain Cummins L9 diesel engines for a potential fuel leak that could cause a fire. The leak occurs between the fuel pump and remote filter head.

    Product
    TIFFIN — TIFFIN PHAETON, ALLEGRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V540000·2021-07-20

    ShowHauler Recalls 2018-2020 Motorhomes Due to Window Adhesive Failure

    ShowHauler is recalling 2018-2020 Garage Coach, Toter Coach, and Motorhome vehicles because window vent adhesive may fail, posing a crash risk.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME, TOTER COACH, GARAGE COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V539000·2021-07-16

    Mercedes-Benz Recalls 2013 GLK250 Diesel Vehicles for Transmission Defect

    Mercedes-Benz is recalling 2013 GLK250 diesel vehicles because incorrect transmission parts may cause fluid leaks or module failure, increasing fire and crash risks.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLK250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V534000·2021-07-15

    2020–2021 Lincoln Aviator Wire Harness May Contact Compressor, Increasing Fire Risk

    2020–2021 Lincoln Aviators with 3.0L engines may have improperly secured wire harnesses that can contact the A/C compressor pulley, risking electrical damage and fire. Ford will inspect and secure the harness free of charge.

    Product
    LINCOLN — LINCOLN AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V536000·2021-07-15

    2020-2021 Ford F-350 Super Duty Pickup Trucks Rear Axle Housing Recall

    Ford is recalling 2020-2021 F-350 Super Duty pickup trucks with 6.7L diesel engines due to rear axle housing that may deform. Driveshaft separation could cause loss of drive power or unexpected vehicle movement, increasing crash risk.

    Product
    FORD — FORD F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V538000·2021-07-15

    Gillig Recalls 2020-2021 Low Floor Vehicles Due to Ammonia Exhaust Risk

    Gillig is recalling 2020-2021 Low Floor vehicles with Cummins L9 Diesel Engines because engine software may allow excessive ammonia into the exhaust, increasing injury risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2021·2021-07-14

    Nonsterile Radial/Femoral Angiography Drapes Recalled for Sticking Defect

    Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.

    Product
    Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2021·2021-07-14

    Verigene Gram Negative Blood Culture Test Recalled for Potential False-Negative Results

    Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.

    Product
    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2021·2021-07-14

    VISIONIST CRT-P Pacemaker Recalled Due to Battery Depletion Risk

    Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.

    Product
    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1992-2021·2021-07-14

    HydraVision Fluoroscopy System Displays Inaccurate Radiation Dose Measurements

    LIEBEL-FLARSHEIM is recalling HydraVision Digital Imaging Systems because the displayed radiation doses are higher than actual delivered doses, potentially affecting clinical decision-making and radiation safety.

    Product
    HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2021·2021-07-14

    FilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results

    BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
    Category
    Medical Device
    Distribution
    49 states
  • HighNHTSA·21V532000·2021-07-14

    New Flyer Recalls 2021 XD35 and XD40 Buses for Ammonia Emissions

    New Flyer is recalling 28 model-year 2021 XD35 and XD40 buses because engine software may allow excessive ammonia emissions from the tailpipe.

    Product
    NEW FLYER — NEW FLYER XD35, XD40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2021·2021-07-14

    ARTIS Angiography System Software Error Causes C-Arm Positioning Deviation

    A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.

    Product
    ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide