The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

576–600 of 4878

  • SevereFDA (Devices)·Z-0001-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Depletion and Delivery Risk

    Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.

    Product
    MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Drugs)·D-0004-2025·2024-10-09

    Gold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil

    FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.

    Product
    Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0003-2025·2024-10-09

    Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil

    Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.

    Product
    Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0016-2025·2024-10-09

    Raisin Bran Muffins Recalled for Undeclared Milk and Wheat Allergens

    The Posh Bakery, Inc. is recalling Whole Grains Bakery Raisin Bran Muffins (6 oz) due to undeclared whey (milk) and wheat allergens and missing allergen labeling.

    Product
    Whole Grains Bakery labeled "Raisin Bran Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 104 7"
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1837-2024·2024-10-09

    Chicken and Duck Eggs Recalled for Potential Salmonella Contamination

    Milo's Poultry Farms is recalling chicken and duck eggs sold in foodservice and consumer packages in Illinois, Michigan, and Wisconsin due to potential Salmonella contamination.

    Product
    Grade A Brown Chicken Eggs, in shell, Bulk 15 dozen. For Foodservice. Keep Refrigerated. Sold with the following brands: 1. Milo's Poultry Farms, N 3873 Valley Road, Bonduel, WI 54107. Organic Eggs from Free Range Hens. 2. M&E Family Farms, Eggs from Free Range Hens. N
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0004-2025·2024-10-09

    Neo-Tee T-Piece Resuscitator circuit flow controller may come apart

    Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.

    Product
    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0003-2025·2024-10-09

    MiniMed Insulin Pumps May Stop Delivering Insulin After Physical Impact

    Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.

    Product
    MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MM
    Category
    Medical Device
    Distribution
    53 states
  • SevereNHTSA·23V591000·2024-10-08

    Harley-Davidson Softail Motorcycles Recalled for Faulty Shock Absorber Fastener

    Harley-Davidson is recalling certain 2018–2023 Softail motorcycles where a fastener securing the rear shock absorber may break, causing tire damage and loss of tire pressure. This can lead to loss of vehicle control and increased crash risk.

    Product
    HARLEY-DAVIDSON — 2021 HARLEY-DAVIDSON FXLRS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V598000·2024-10-08

    2020-2022 Ford Explorer Engine Compartment Fire Risk Recall

    Certain 2020-2022 Ford Explorers may experience engine failures that release oil and fuel vapors, risking engine compartment fires. Ford will update the engine control software and inspect for bearing damage.

    Product
    FORD — 2020 FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V330000·2024-10-05

    Lincoln Corsair transmission control software defect causes unexpected neutral shift

    Ford is recalling 2021-2022 Lincoln Corsair vehicles due to a hybrid powertrain control module software defect that may cause the transmission to shift into neutral unexpectedly, resulting in loss of drive power and increased crash risk.

    Product
    LINCOLN — 2021 LINCOLN CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3090-2024·2024-10-02

    ParaPAC Plus 310 ventilator connector may detach and stop ventilation

    Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.

    Product
    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3153-2024·2024-10-02

    Ivenix Infusion Pump Software Recalled for Potential Malfunctions

    Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.

    Product
    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3134-2024·2024-10-02

    Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk

    Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.

    Product
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·23V110000·2024-10-02

    2023 Lucid Air propulsion system electrical switches may fail unexpectedly

    Lucid is recalling certain 2022-2023 Air vehicles because electrically activated contactor switches in the propulsion system may unexpectedly open, cutting power to the electric motors and increasing the risk of a crash.

    Product
    LUCID — 2023 LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3135-2024·2024-10-02

    CARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk

    Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3137-2024·2024-10-02

    CARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability

    Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereCPSC·24377·2024-09-26

    John Deere Compact Utility Tractors Recalled for Brake Failure Hazard

    Deere & Company is recalling about 147,900 John Deere 1023E, 1025R, and 2025R Compact Utility Tractors because the front bell crank in the brake linkage can fail, causing loss of braking and crash risk. Four failures have been reported, including one hospitalization and two impact injuries.

    Product
    John Deere 1023E, 1025R, and 2025R Compact Utility Tractors
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3083-2024·2024-09-25

    Baxter EXACTAMIX pharmaceutical compounding inlets recalled for particulate contamination

    Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3082-2024·2024-09-25

    Baxter EXACTAMIX Inlet Compounders Recalled for Particulate Matter Contamination

    Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1815-2024·2024-09-25

    Supreme Peppers Products Recalled for Possible Listeria Contamination

    GBC Food Services, LLC is recalling multiple Supreme Peppers products distributed in Indiana due to possible contamination with Listeria Monocytogenes. Consumers should not consume these products.

    Product
    Supreme Peppers Tri Blend 8-50053-68534 8 OZ Supreme Jalapenos Diced 8-50053-68536 7 OZ Supreme Peppers W/Onions 8-50053-68538 7 OZ Supreme Peppers Snacking 8-50053-68553 12 OZ
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1816-2024·2024-09-25

    Supreme Guacamole and Pico Products Recalled for Possible Listeria Contamination

    GBC Food Services is recalling Supreme brand guacamole and pico/guacamole products distributed in Indiana due to possible contamination with Listeria monocytogenes.

    Product
    Supreme Guacamole Chunky Mild 8-50053-68588 17 OZ Supreme Guacamole Chunky Medium 8-50053-68589 17 OZ Supreme Pico/Guacamole 8-50054-89443 16 OZ Supreme Pico/Guacamole
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1809-2024·2024-09-25

    Bliss Tree Millet Butter Murukku Recalled for Undeclared Sesame and Milk Allergens

    Bliss Tree Millet Butter Murukku products are being recalled due to undeclared sesame and milk allergens. Affected products were distributed to retailers and online customers in multiple states.

    Product
    Bliss Tree Millet Butter Murukku 200g UPC:8906087451631. Packaged in box, 13 boxes per cases. Bliss Tree Millet Butter Murukku 400g UPC:8906087452850. Packaged in pouches, 8 pouches per cases.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1818-2024·2024-09-25

    Marabou Sea Salt Chocolate Bars Recalled for Undeclared Allergens

    BonBon NYC LLC is recalling Marabou Sea Salt Chocolate Bars due to undeclared almonds, wheat, and tree nuts. Consumers allergic to these ingredients should not consume the product.

    Product
    Marabou Sea Salt Chocolate Bar; 185g; yellow plastic packaging and the word 'havvsalt', the Swedish word for "sea salt"; product is a flat chocolate bar
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3085-2024·2024-09-25

    Baxter ExactaMix Inlets Recalled for Particulate Contamination Risk

    Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.

    Product
    Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1817-2024·2024-09-25

    Supreme Vegetables Recalled Due to Possible Listeria Contamination

    Yummi Sushi is recalling Supreme vegetable products distributed in Indiana due to possible Listeria monocytogenes contamination. Consumers should not consume these products.

    Product
    Supreme Grilling Veggies 8-50053-68584 19 OZ Supreme Vegetable Kabobs 8-50053-68585 27 OZ Supreme Vegetable Bowl 8-60010-50713 26 OZ
    Category
    Food
    Distribution
    0 states