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.

26651–26675 of 50462

  • HighNHTSA·19V022000·2019-01-02

    Pierce Aerial Vehicles Recalled for Unexpected Ladder Rotation Defect

    Pierce Manufacturing is recalling 2004-2018 aerial vehicles because the aerial device may unexpectedly rotate right during extension, increasing injury risk.

    Product
    PIERCE — PIERCE QUANTUM, VELOCITY, IMPEL, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0683-2019·2019-01-02

    Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts

    Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.

    Product
    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0674-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits

    Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 units distributed nationwide.

    Product
    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0753-2019·2019-01-02

    Sargento Recalls Frozen Unbreaded Egg and French Onion Samples for Contamination

    Sargento Foods is recalling specific frozen unbreaded egg and French onion samples due to potential Listeria monocytogenes or Salmonella contamination.

    Product
    Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sample Number 18-0115.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0663-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Food)·F-0754-2019·2019-01-02

    Sargento Recalls Frozen Unbreaded Egg and Cheese Products for Listeria Risk

    Sargento Foods is recalling specific frozen unbreaded egg and cheese products due to potential Listeria monocytogenes or Salmonella contamination.

    Product
    Frozen Unbreaded Egg, Gouda, caramelized onion. Sample Number 18-0116.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0661-2019·2019-01-02

    ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems

    ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.

    Product
    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0682-2019·2019-01-02

    Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch

    Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.

    Product
    ABL800 analyzer, model numbers 393-800 and 393-801.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2019·2019-01-02

    Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error

    Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.

    Product
    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0672-2019·2019-01-02

    Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.

    Product
    AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.

    Product
    ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0679-2019·2019-01-02

    RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

    RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0680-2019·2019-01-02

    Baxter Recalls GEM Coupler Forceps Due to Potential Rust

    Baxter Healthcare is recalling 123 GEM Coupler Forceps units because of potential rust on the devices. The recall covers nationwide and international distribution.

    Product
    GEM Coupler Forceps, GEM4183C, packaged individually.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V940000·2018-12-31

    Arcimoto Recalls 2017 FUV Motorcycles Due to Brake Fitting Defect

    Arcimoto is recalling 2017 FUV motorcycles because incorrect fittings in the braking system may cause fluid leaks, reducing brake effectiveness and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V943000·2018-12-31

    Arcimoto Recalls 2017-2018 FUV Motorcycles for Headlight Spacing Defect

    Arcimoto is recalling 2017-2018 FUV motorcycles because the headlights may be spaced too far apart, making the vehicle difficult to recognize as a motorcycle in the dark.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V942000·2018-12-31

    Arcimoto Recalls 2017-2018 FUV Motorcycles for Missing Side Reflectors

    Arcimoto is recalling 2017-2018 FUV motorcycles because the rear light assembly lacks required side reflex reflectors, reducing visibility and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V941000·2018-12-31

    Arcimoto Recalls 2017-2018 FUV Motorcycles for Turn Signal Placement

    Arcimoto is recalling 2017-2018 FUV motorcycles because front turn signals are not positioned as required by federal safety standards, potentially reducing visibility.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V935000·2018-12-31

    Subaru Recalls 2018 Models for Rearview Camera Software Defect

    Subaru is recalling 2018 Legacy, Outback, and BRZ vehicles because a software issue may prevent the rearview camera from displaying an image while backing up.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, BRZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V933000·2018-12-27

    Forest River Recalls 2019 Salem and Wildwood Trailers for Fire Risk

    Forest River is recalling 2019 Salem and Wildwood recreational trailers because the power cord hatch is located above the water heater exhaust, which may cause melting and increase fire risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2019·2018-12-26

    Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination

    Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0742-2019·2018-12-26

    ASK Foods Recalls Rotini Salad Due to Listeria and Salmonella Risk

    ASK Foods Inc is recalling Taste of Inspirations Rotini Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Taste of Inspirations Rotini Salad, Net Wt. 13 oz., Pre-pack Container sold to consumer by retailer, 4 lb. Bulk Container sold from the deli
    Category
    Food
    Distribution
    20 states