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.

20926–20950 of 50413

  • HighFDA (Food)·F-0306-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard for Pasteurization Violation

    Barron County Organics is recalling 20 Mile Vanilla Bean Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Vanilla Bean Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48804. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1121-2021·2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to reports of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0290-2021·2021-02-24

    Barron County Organics Frozen Custard Recalled for Pasteurization Violation

    Barron County Organics is recalling 20 Mile Black Cherry Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Black Cherry Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48807. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1126-2021·2021-02-24

    Confirm Biosciences Recalls Orient Gene COVID-19 Rapid Test Cassettes

    Confirm Biosciences is recalling Orient Gene COVID-19 Rapid Test Cassettes because they were distributed outside Emergency Use Authorization and not validated for fingerstick use.

    Product
    Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0304-2021·2021-02-24

    Barron County Organics Frozen Custard Recalled for Pasteurization Violation

    Barron County Organics is recalling 20 Mile Salted Chocolate Caramel Crunch Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Salted Chocolate Caramel Crunch, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48801. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0307-2021·2021-02-24

    Treehouse Foods Recalls Happy Belly Mayo Light Mayonnaise Due to Undeclared Egg

    Treehouse Foods is recalling 30 jars of Happy Belly Mayo Light Mayonnaise because the product contains undeclared egg. The items were distributed as consumer samples via the Amazon Vine program.

    Product
    Happy Belly Mayo Light Mayonnaise 30 FL OZ Plastic Jar Item B08B6T9RC6
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0301-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard Due to Pasteurization Failure

    Barron County Organics is recalling 20 Mile Raspberry Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Raspberry, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48812. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0296-2021·2021-02-24

    Barron County Organics Recalls Unpasteurized Organic Frozen Custard

    Barron County Organics is recalling 20 Mile Maple Cream Organic Frozen Custard because the ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Maple Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48806. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·21087·2021-02-24

    Urban Outfitters Recalls Margo Taper Candle Holders Due to Fire Hazard

    Urban Outfitters is recalling Margo Taper Candle Holders because they can catch fire if they contact the flame. One fire incident was reported, with no injuries.

    Product
    Margo Taper Candle Holders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2021·2021-02-24

    Getinge CM320 Washer Disinfector Recalled for Hose Deformation Risk

    Getinge is recalling CM320 Series Washer Disinfectors because plastic inlet hose connections may deform or break, potentially causing water leaks and burns.

    Product
    Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2021·2021-02-24

    Biomet Recalls Mislabelled 25mm Shoulder Prosthesis Central Screws

    Biomet is recalling 49 units of 25mm central screws for shoulder prostheses because they were mislabeled as 25mm but are actually 40mm.

    Product
    Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0291-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard for Pasteurization Failure

    Barron County Organics is recalling 20 Mile Chocolate Chip Cookie Dough Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Chocolate Chip Cookie Dough, Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48803. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0300-2021·2021-02-24

    Barron County Organics Recalls Unpasteurized Frozen Custard

    Barron County Organics is recalling 20 Mile Pumpkin Spice Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Pumpkin Spice, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48814. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·21V110000·2021-02-24

    2021-2022 Polestar 2 vehicles recalled for battery control software glitch

    Polestar is recalling certain 2021-2022 Polestar 2 vehicles. A software issue in the Battery Energy Control Module may cause the high voltage system to disconnect, resulting in loss of drive power and increased crash risk.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0305-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard for Pasteurization Violation

    Barron County Organics is recalling 20 Mile Strawberry Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Strawberry, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48813. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·21086·2021-02-24

    Northern Tool Recalls Powerhorse Generators Due to Electrical Shock Hazard

    Northern Tool & Equipment is recalling Powerhorse 13000ES portable generators due to a wiring error that can cause electrical shock. No injuries have been reported.

    Product
    Northern Tool & Equipment Powerhorse 13000ES Portable Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2021·2021-02-24

    Baxter Recalls Gambro Hemodialysis Blood Sets Due to Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis because of complaints regarding kinked access lines observed during treatment.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1129-2021·2021-02-24

    GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Issue

    GE Healthcare is recalling 96 Revolution CT systems because a damaged or missing table pinch protector may expose sharp screws, posing a laceration risk.

    Product
    System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2021·2021-02-24

    GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Defect

    GE Healthcare is recalling Revolution CT and Revolution CT ES systems because damaged or missing table pinch protectors may expose sharp screws, posing a laceration risk.

    Product
    System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2021·2021-02-24

    LumiraDx SARS-CoV-2 Antigen Test Strips Recalled for False Positives

    LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips due to potential false positive results that could lead to unnecessary treatment or quarantine.

    Product
    LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests.…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0294-2021·2021-02-24

    Barron County Organics Recalls Dark Chocolate Frozen Custard for Pasteurization Failure

    Barron County Organics is recalling 20 Mile Dark Chocolate Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Dark Chocolate, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48805. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0292-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard for Pasteurization Violation

    Barron County Organics is recalling 20 Mile Coconut Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Coconut, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48810. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·21085·2021-02-24

    Potter Electric Recalls Addressable Pull Stations Due to Fire Alarm Failure

    Potter Electric is recalling specific addressable pull stations because the handle may fail to activate the fire alarm, posing a risk of failure to alert occupants to a fire.

    Product
    Potter Electric Addressable Pull Stations Single/Dual Action
    Category
    Consumer Product
    Distribution
    Distributed nationwide