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.

4026–4050 of 29102

  • SevereCPSC·24722·2023-11-30

    Polaris Model Year 2022 Patriot 850 MATRYX Snowmobiles Recalled for Injury Hazard

    Polaris is recalling about 2,900 Model Year 2022 Patriot 850 MATRYX snowmobiles because the ring gear on the primary clutch can fail, causing clutch components to come loose and creating an injury hazard. Nine failures have been reported, including one injury.

    Product
    Polaris Snowmobiles, Model Year 2022 PATRIOT 850 MATRYX RMK, INDY and SWITCHBACK
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2024·2023-11-29

    VariSoft Infusion Set Model 1002828 Recalled for Connector Detachment Risk

    The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.

    Product
    VariSoft infusion set, Model Number 1002828
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0232-2024·2023-11-29

    VariSoft Infusion Set recalled for defective connector prone to unintended disconnection

    Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.

    Product
    VariSoft infusion set, Model Number 1002827
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0134-2024·2023-11-29

    FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2024·2023-11-29

    Eye drops recalled for non-sterility due to bacterial contamination

    Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2024·2023-11-29

    Lubricating Tears Eye Drops Recalled for Non-Sterility and Bacterial Contamination

    Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.

    Product
    Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2024·2023-11-29

    LEADER Lubricant Eye Drops Recalled Nationwide for Non-Sterility Concerns

    LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0136-2024·2023-11-29

    LEADER Lubricant Eye Drops Recalled for Non-Sterility and Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.

    Product
    LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2024·2023-11-29

    Midazolam Injectable Recalled for Silicone Particulate Matter Contamination

    Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.

    Product
    Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2024·2023-11-29

    FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination

    Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V803000·2023-11-28

    Cake Recalls 2020-2022 Osa Flex Electric Mopeds for Steering Defect

    Cake is recalling 2020-2022 Osa Flex electric mopeds because the aluminum steering column may fatigue and break, causing a sudden loss of steering.

    Product
    CAKE — CAKE OSA FLEX ELECTRIC MOPED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V800000·2023-11-28

    2024 Ford Mustang brake pedal defect increases crash risk

    Ford is recalling certain 2024 Mustang vehicles because the brake pedal assembly may have been manufactured incorrectly, causing a loose brake pedal. A loose brake pedal can result in loss of braking function, increasing the risk of a crash.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V798000·2023-11-26

    KME Fire Trucks Recalled for Parking Brake Defect

    KME is recalling 2021-2023 fire trucks because a valve defect may delay parking brake engagement, increasing crash risk.

    Product
    KME — KME redundant PREDATOR, SEVERE SERVICE, PREDATOR, redundant PANTHER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V797000·2023-11-24

    BMW Recalls 2014-2015 X3, X4, and X5 Models for Airbag Defect

    BMW is recalling specific 2014-2015 X3, X4, and X5 vehicles because the driver's airbag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    BMW — BMW X3, X5, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V795000·2023-11-23

    Micro Bird Recalls G5 School Buses Due to Wheelchair Track Defect

    Micro Bird is recalling certain G5 school buses because wheelchair track anchorages may detach during a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E090000·2023-11-22

    Chrysler Recalls Mopar Hybrid Service Kit Battery Packs Due to Fire Risk

    Chrysler is recalling specific Mopar Hybrid Service Kit Battery Packs because they may fail internally and cause a fire while parked or driving.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0423-2024·2023-11-22

    UNICORN Ice-Cream Base Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors LLC is recalling 216 units of UNICORN Ice-Cream Base distributed in Florida due to undeclared milk allergen and color additives (FD&C red #5, blue #1, red #3, red #40, yellow #5).

    Product
    UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0453-2024·2023-11-22

    Paradise Flavors Frozen Chocolate Ice Cream Recalled for Undeclared Milk and Soy

    Paradise Flavors LLC is recalling frozen chocolate ice cream (4 OZ/120 ML packages) distributed in Florida due to undeclared milk and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    CHOCOLATE, ice-cream base, chocolate powder, natural flavoring,. PARADISE FLAVORS, 4 OZ, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0444-2024·2023-11-22

    Chocolate ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC is recalling Chocolate with Almonds ice-cream products due to undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with these allergies should discard the product.

    Product
    CHOCOLATE WITH ALMONDS, ice-cream base, chocolate powder, natural flavoring, PARADISE FLAVORS, 4oz, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0449-2024·2023-11-22

    Cookies And Cream Frozen Product Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Paradise Flavors LLC is recalling 318 units of Cookies And Cream frozen product (4 oz) due to undeclared allergens: milk, soy, and wheat. The product was distributed in Florida.

    Product
    Cookies And Cream, distributed by Paradise Flavors LLC, 4 OZ, 120ML, Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0432-2024·2023-11-22

    Paradise Flavors Strawberries and Cream ice cream base recalled for undeclared milk allergen

    Paradise Flavors LLC is recalling Strawberries and Cream ice cream base (4 oz) due to undeclared milk allergen. Approximately 86 units from the latest production were distributed in Florida.

    Product
    Strawberries and Cream, ice-cream base, natural flavoring. Paradise Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0438-2024·2023-11-22

    Frozen Chocolate Razzberry Cake Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC is recalling Chocolate Razzberry Cake (Gancito) frozen dessert due to undeclared milk, peanuts, soy, and wheat allergens, plus undeclared color additives.

    Product
    CHOCOLATE RAZZBERRY CAKE (GANCITO). INGREDIENTS: Icecream base, Natural flavor, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0408-2024·2023-11-22

    Ice cream recall: Undeclared egg allergen in Guilt Free vanilla

    TH Searcy LLC is recalling Guilt Free No Sugar Added Ice Cream due to undeclared egg allergen. The recall affects 34,500 retail units distributed through Walmart, Kroger, and Associated Wholesale Grocers across nine states.

    Product
    Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1.5qts
    Category
    Food
    Distribution
    9 states