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.

9476–9500 of 29156

  • SevereFDA (Drugs)·D-1363-2020·2020-07-08

    MasterPharm Recalls Compounded Minoxidil, Biotin, and Spironolactone Capsules

    MasterPharm LLC is recalling compounded Minoxidil/Biotin/Spironolactone capsules due to elevated levels of minoxidil and biotin. The product was distributed in Florida and Maryland.

    Product
    Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1008-2020·2020-07-08

    Hill Country Fare Citrus Punch Drink Recalled for Undeclared Milk

    Hill Country Fare Citrus Punch Drink is being recalled due to potential undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Hill Country Fare Citrus Punch Drink 1 GAL CONT. NET. 3.78L Contains 0% Juice UPC 4122081863
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1359-2020·2020-07-08

    Koala Hand Sanitizer Recalled for Subpotent Ethanol and Undeclared Isopropyl Alcohol

    Beaming White LLC is recalling Koala Hand Sanitizer because the ethanol content is below the label claim and undeclared isopropyl alcohol is present.

    Product
    Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1019-2020·2020-07-08

    Trident Seafoods Recalls Imitation Crab Supreme Due to Undeclared Egg

    Trident Seafoods is recalling Gordon Choice Imitation Crab Supreme Style because the product may contain undeclared egg white.

    Product
    Gordon Choice Imitation Crab Supreme Style, Net Wt 40 oz (2 lb 8 oz) Keep Frozen. UPC 93901-71212. For Distribution exclusively by Gordon Food Service Wyoming, MI 49509
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2411-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component vibration issue may cause the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2455-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2463-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips because internal tests identified potential breaches in the sterile barrier.

    Product
    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2413-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component vibration issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1364-2020·2020-07-08

    Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA

    Preferred Pharmaceuticals is recalling 144 bottles of Metformin HCl Extended Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.

    Product
    Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2439-2020·2020-07-08

    LivaNova SCP Pump Control Panel Recalled for Rotary Knob Wear

    LivaNova is recalling eight SCP Pump Control Panels because premature wear of the angle encoder may make the rotary knob difficult or impossible to rotate during cardiopulmonary bypass.

    Product
    Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2440-2020·2020-07-08

    LivaNova SCP Pump Control Panel Recalled Due to Rotary Knob Wear

    LivaNova is recalling 24 SCP Pump Control Panels because the rotary knob may fail to rotate due to premature wear, risking patient injury during surgery.

    Product
    Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2451-2020·2020-07-08

    LivaNova Recalls Sterile Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Drugs)·D-1358-2020·2020-07-08

    Koala Hand Sanitizer Recalled for Subpotent Ethanol and Undeclared Isopropyl Alcohol

    Beaming White LLC is recalling Koala Hand Sanitizer because the active ingredient ethanol was tested below the label claim and undeclared isopropyl alcohol was present.

    Product
    Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2415-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2412-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1357-2020·2020-07-08

    Koala Hand Sanitizer Recalled for Subpotent Alcohol and Undeclared Ingredients

    Beaming White LLC is recalling Koala Hand Sanitizer because the ethanol level is below the label claim and it contains undeclared isopropyl alcohol.

    Product
    Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V395000·2020-07-06

    Mercedes-Benz Recalls AMG Models Due to Electronic Stability Control Software Error

    Mercedes-Benz is recalling 2019-2020 AMG models because incorrect Electronic Stability Program software may cause the system to react inaccurately, increasing the risk of a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63 S, AMG GT63S, AMG GT63, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V391000·2020-07-02

    Airstream Recalls 2020-2021 Motorhomes Due to Suspension Bolt Defect

    Airstream is recalling 2020-2021 Atlas and Interstate motorhomes because suspension bolts may be too long, potentially breaking and affecting vehicle handling.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V388000·2020-07-02

    Brake Hose Chafing in 2019-2021 Entegra Qwest and Jayco Motorhomes

    Jayco recalls 2019-2021 Entegra Qwest and Jayco Melbourne motorhomes because the front fender liner can chafe the brake hose, causing brake fluid loss and extended stopping distances.

    Product
    JAYCO — JAYCO, ENTEGRA MELBOURNE PRESTIGE, QWEST, MELBOURNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V387000·2020-07-02

    Land Rover Recalls Range Rover Models Due to Door Latch Defect

    Land Rover is recalling 2013-2016 Range Rover and 2014-2016 Range Rover Sport vehicles because doors may be unlatched despite appearing closed, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V392000·2020-07-02

    Gillig Recalls 2013-2020 Low Floor Buses Due to Steering Defect

    Gillig is recalling 2013-2020 Low Floor buses because a steering component may fail, causing a loss of power assist and increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V393000·2020-07-02

    Hyundai Recalls 2011-2012 Models for Accessory Socket Fire Risk

    Hyundai is recalling 272,126 vehicles because an over-tightened 12V accessory socket may overheat and cause a fire.

    Product
    HYUNDAI — HYUNDAI SONATA HYBRID, ELANTRA, ACCENT, VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide