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.

7976–8000 of 52968

  • HighCPSC·24316·2024-07-25

    Besrey Twins Strollers Recalled for Entrapment, Fall, and Choking Hazards

    Stiger Inc. is recalling about 3,045 Besrey Twins Strollers sold on Amazon due to entrapment, fall, and choking hazards that violate federal stroller safety regulations. Consumers should stop using the product immediately.

    Product
    Besrey Twins Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V560000·2024-07-25

    Nissan Ariya inverter software may shut down the EV system

    Nissan is recalling certain 2023 Ariya vehicles because the inverter software may misdiagnose an error and shut down the EV system, resulting in a loss of drive power.

    Product
    NISSAN — NISSAN ARIYA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24317·2024-07-25

    2024 Arctic Cat Mountain 600 Snowmobiles Recalled Due to Crash Hazard

    Textron Specialized Vehicles is recalling about 600 of the 2024 Arctic Cat Mountain 600 Snowmobiles because a pin on the steering knuckle u-joint may not be properly installed, allowing it to come loose and cause loss of steering control.

    Product
    2024 Arctic Cat Mountain 600 Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2410-2024·2024-07-24

    Knee Prosthesis Tibial Component Screws Cannot Be Loosened During Surgery

    The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.

    Product
    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2024·2024-07-24

    Abbott Proclaim Plus 5 Pulse Generator Battery Life Shorter Than Labeled

    Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.

    Product
    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2024·2024-07-24

    IV Pump Sets Recalled for Potential Backcheck Valve Malfunction

    B. Braun Infusomat SPACE IV pump sets may experience backcheck valve malfunction, causing medication backflow between containers and preventing proper IV line priming. This could result in adverse drug reactions, incorrect medication doses, or medication loss.

    Product
    Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration

    B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V552000·2024-07-24

    A&J Vans Recalls 2023 Ford Transit Vehicles Due to Seat Defect

    A&J Vans is recalling 2023 Ford Transit vehicles because the seat recliner mechanism may fail to engage, increasing injury risk during a crash.

    Product
    A&J VANS — A&J VANS FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2024·2024-07-24

    Infusion pump IV administration set recalled for backcheck valve malfunction risk

    B. Braun is recalling Infusomat UNIV. 15 DROP PUMP SET infusion sets due to potential backcheck valve malfunction that may cause medication to flow backward into primary IV containers and prevent proper priming, risking adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2024·2024-07-24

    Infusion Pump Component Valve Malfunction May Cause Medication Backflow

    B. Braun's Infusomat infusion pump component can malfunction, causing medication to flow backward from secondary IV lines into primary lines, potentially resulting in improper medication delivery and patient harm.

    Product
    Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2024·2024-07-24

    Qiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results

    A heating defect in the Qiagen QIAcube Connect MDx may prevent proper incubation temperatures below 40°C, potentially affecting diagnostic test results.

    Product
    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2024·2024-07-24

    IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow

    B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1487-2024·2024-07-24

    Lundberg Family Farms Rice Recalled Due to Possible Rodent-Origin Foreign Object

    Wehah Farms is recalling Lundberg Family Farms Sustainable Wild Blend Gourmet Rice because the product may contain a foreign object of apparent rodent origin. Consumers should not consume the recalled product.

    Product
    Lundberg Family Farms Sustainable Wild Blend Gourmet Rice, 1 lb poly bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2355-2024·2024-07-24

    Knee walker recalled for tiller separation that may cause falls

    Medical Depot is recalling the Nitro Glide Knee Walker (model 791RD) because the tiller can separate from the base assembly, potentially causing users to fall. The recall affects 667 units distributed nationwide and in Canada.

    Product
    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1502-2024·2024-07-24

    Canned coffee beverages recalled for potential under-processing

    Snapchill LLC is recalling approximately 549,146 cans of ready-to-drink coffee beverages distributed nationwide and in Canada due to potential under-processing.

    Product
    Coffee + Non-Dairy Creamer + Sugar Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Nitro with Sugar and Non-Dairy Creamer, 12 oz. UPC 7 83970-58494 6. 2. Euphoria Coffee Sweetened Latte, 12 oz. UPC 8 10149-37096 0. 3. Kahawa 1893 C
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2024·2024-07-24

    Canned Coffee Beverage Recalled for Potential Under-Processing Concerns

    Snapchill, LLC is recalling Fire Grounds Coffee Co Mo Mocha canned beverages nationwide due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee + Chocolate Syrup and Sugar Canned Beverage packaged under the following brands and sizes: 1. Fire Grounds Coffee Co Mo Mocha, 12 oz. UPC 8 50050-85505 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2024·2024-07-24

    Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.

    Product
    Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2024·2024-07-24

    Infusomat UNIV. 15 IV Pump Set Recalls Due to Backcheck Valve Malfunction

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets because the backcheck valve may malfunction, potentially causing medication backflow or loss, which could lead to adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2024·2024-07-24

    Fludrocortisone Acetate Tablets recalled nationwide due to failed impurity and degradation specifications

    Teva Pharmaceuticals is recalling Fludrocortisone Acetate Tablets 0.1mg nationwide and in Puerto Rico due to impurities and degradation substances exceeding specification limits.

    Product
    Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0602-2024·2024-07-24

    Cardura XL Tablets Recalled for Failed Impurities and Degradation Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) 4mg tablets due to failed impurities and degradation specifications. The recall affects 12,691 bottles distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1497-2024·2024-07-24

    FDA Recalls Black Coffee Beverages Due to Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of Black Coffee + Chocolate Syrup canned beverages marketed under Bold Bean Coffee Roasters and Larry's Coffee brands due to potential under-processing that may allow pathogenic growth.

    Product
    Black Coffee + Chocolate Syrup Canned Beverage packaged under the following brands and sizes: 1. Bold Bean Coffee Roasters The Chocolate One, 12 oz. UPC 8 10149-37108 0. 2. Larry's Coffee Nitro Mocha, 12 oz. UPC 8 50050-85512 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2024·2024-07-24

    Canned black coffee and maple syrup beverage recalled for potential under-processing

    Snapchill, LLC is recalling Mud LLC Maple Mud canned black coffee with maple syrup beverages (12 oz, UPC 854555007058) nationwide and in Canada due to potential under-processing. Affected products have expiration dates from June 16, 2024 to April 16, 2025.

    Product
    Black Coffee + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Mud LLC Maple Mud, 12 oz. UPC 8 54555-00705 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2024·2024-07-24

    Hip Prosthesis Component Mislabeled; Package Size May Not Match Device

    Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.

    Product
    UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2380-2024·2024-07-24

    Infusomat IV Pump Set Recalled for Backcheck Valve Malfunction

    The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.

    Product
    Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
    Category
    Medical Device
    Distribution
    Distributed nationwide