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.

7476–7500 of 29119

  • SevereFDA (Food)·F-0196-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella Oranienburg Contamination

    HelloFresh has recalled meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected products were produced in Week 35 (starting August 25, 2021) and distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 4-12-14-18-23-25-AA from Production Week 35 (production week start date: 8/25/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0231-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall

    The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0224-2022·2021-11-24

    FDA Recalls Scrip Ultrasound Gel for Potential Bacterial Contamination

    Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.

    Product
    Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2022·2021-11-24

    LOTRIMIN AF Powder Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare is recalling LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray because it was manufactured at a facility where other lots were found contaminated with benzene. The recall affects multiple lot numbers distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0176-2022·2021-11-24

    Greenhead Lobster Frozen Cooked Meat Recalled for Listeria Contamination

    Greenhead Lobster brand frozen cooked lobster meat products may be contaminated with Listeria monocytogenes. The recall affects multiple lobster meat products sold in six states.

    Product
    Greenhead Lobster brand Frozen Cooked Claw and Knuckle Meat - 2lbs; Greenhead Lobster brand Frozen Cooked Claw and Knuckle Meat - 1lb; Greenhead Lobster brand Frozen Cooked Broken Meat - 2lbs; Greenhead Lobster brand Frozen Cooked Tail Meat - 2lbs; Greenhead Lobster brand Fro
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0205-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HelloFresh is recalling specific EveryPlate meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. Affected product codes from production week 08/25/2021 are being recalled nationwide.

    Product
    EveryPlate Meal Kit Product Codes 87-88-89-90-91-94-101 from Production Week 35 (production week start date: 08/25/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0173-2022·2021-11-24

    Red Onions Recalled for Potential Salmonella Contamination

    Sysco Merchandising and Supply is recalling 2,902 cases of red onions packed in 5-pound bags due to potential Salmonella contamination. The onions were distributed to multiple states.

    Product
    Red onions packed in 5 pound bag
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-0232-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall

    Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-veno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0225-2022·2021-11-24

    Scrip Creme ultrasound lotion recalled for bacterial contamination

    Scrip Creme All Purpose Lotion is being recalled due to bacterial contamination in this ultrasound coupling lotion. The product—1001 gallons in lots distributed between August 2018 and August 2021—was distributed nationwide.

    Product
    Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V920000·2021-11-23

    Toyota Tundra and Sequoia Power Steering Gear Assembly Defect Recall

    Toyota is recalling 2007-2021 Tundra and 2008-2022 Sequoia vehicles due to defective power steering gear assemblies that can leak oil, causing sudden loss of power steering assist and increased crash risk.

    Product
    TOYOTA — TOYOTA SEQUOIA, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V917000·2021-11-22

    2022 Nissan Frontier Missing Tow Hitch Affects Fuel Tank Integrity

    2022 Nissan Frontier Crew Cab Long Bed trucks lack an installed tow hitch, compromising fuel tank structural integrity. In a rear crash, the leaf spring could contact the fuel tank, risking fire or injury.

    Product
    NISSAN — NISSAN FRONTIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V912000·2021-11-21

    Tesla Recalls 2020-2022 Model Y Vehicles for Suspension Fracture Risk

    Tesla is recalling 2020-2022 Model Y vehicles because front and rear suspension knuckles may fracture, potentially causing suspension links to separate and increasing crash risk.

    Product
    TESLA — TESLA MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V906000·2021-11-19

    PACCAR recalls Peterbilt and Kenworth trucks for brake system defect

    PACCAR is recalling approximately 908 Peterbilt and Kenworth commercial trucks from 2019-2022 for a brake defect that may cause unintended vehicle movement during winching operations. Software updates will be provided free of charge.

    Product
    PETERBILT — PETERBILT, KENWORTH 389, 579, W990, 537
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V909000·2021-11-19

    Mercedes-Benz Recalls 2021 GLE Models for Electric Heater Fire Risk

    Mercedes-Benz is recalling 2021 GLE 450 and AMG GLE53 vehicles because improperly tightened bolts on the electric heater may cause wiring to overheat, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLE53, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V905000·2021-11-19

    KME Recalls 2021-2022 Predator Emergency Vehicles Due to Axle Defect

    KME is recalling 2021-2022 Predator emergency vehicles because a rear axle drive pinion may fracture, potentially engaging the parking brake unexpectedly and increasing crash risk.

    Product
    KME — KME redundant PREDATOR, PREDATOR PANTHER, PREDATOR SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V907000·2021-11-19

    BMW Recalls Diesel Vehicles Due to EGR Cooler Leak Fire Risk

    BMW is recalling specific 2013-2018 diesel models because an EGR cooler leak can cause a melting intake manifold, increasing the risk of a fire.

    Product
    BMW — BMW 740LD, 328D, 535D, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22021·2021-11-18

    Goodman evaporator coil drain pans recalled for fire hazard

    Goodman Manufacturing is recalling evaporator coil drain pans used in residential gas furnaces because the plastic drain pan can overheat, melt, and deform, posing a fire hazard. The company has received 23 reports of fire incidents involving the drain pans, resulting in significant fire and smoke damage to residences.

    Product
    Evaporator coil drain pans installed with residential condensing gas furnaces in an up-flow configuration
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V899000·2021-11-18

    Spartan Fire Recalls 2020-2022 Emergency Vehicles Due to Axle Defect

    Spartan Fire is recalling 2020-2022 MetroStar, FC-94, and Gladiator emergency vehicles because a rear axle drive pinion may fracture, increasing crash risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE FC-94, METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V893000·2021-11-17

    Motorhome seat belt retractor defect affects child restraint systems

    Jayco recalls certain 2021-2022 motorhomes with defective seat belt retractors that may fail to secure child restraint systems during crashes. Dealers will replace the retractors free of charge.

    Product
    JAYCO — JAYCO, ENTEGRA SWIFT, ETHOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V892000·2021-11-17

    2021 Volkswagen Atlas and 2020-2021 Cross Sport recalled for air bag water damage

    Volkswagen is recalling certain 2021 Atlas and 2020-2021 Cross Sport vehicles whose air conditioning drain tube can become blocked, allowing water to damage the air bag control module and potentially trigger inadvertent air bag deployment.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0128-2022·2021-11-17

    MIC/B Complex/Chrom/Carn/Lido Injectable Lacks Sterility Assurance

    Talon Compounding Pharmacy is recalling one lot of MIC/B Complex/Chrom/Carn/Lido Injectable (Lot 07292021:73, BUD 10/30/2021) distributed nationwide due to lack of assurance of sterility. Patients who received this injectable product should consult their healthcare provider.

    Product
    MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0121-2022·2021-11-17

    Talon Compounding Pharmacy IVME SUPER B Injectable Recalled for Sterility Assurance

    Talon Compounding Pharmacy is recalling IVME SUPER B Injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.

    Product
    IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0162-2022·2021-11-17

    Talon Compounding Pharmacy Injectable Steroid Mixture Recall for Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable anabolic steroid mixture (Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 2mg/mL in oil) due to lack of assurance of sterility. The recall affects products distributed throughout the United States.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states