The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

13276–13300 of 29186

  • SevereNHTSA·18V802000·2018-11-14

    Ford Recalls 2019 Super Duty Trucks for Transmission Defect

    Ford is recalling 2019 F-250, F-350, and F-450 Super Duty trucks because an incorrect transmission casting may allow unintended vehicle movement.

    Product
    FORD — FORD F-250 SD, F-350 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0617-2019·2018-11-14

    Sam Dry Fruits Recalls Pistachios Due to Salmonella Risk

    Sam Dry Fruits and Enterprises Inc. is recalling 25 lb. bags of inshell pistachios because a positive Salmonella test was received during a supplier investigation.

    Product
    Inshell R/S 21/25 US- Select Pistachios; NET WT. 25 lb. (11.34kg) Product of the USA Production Date: 8/2018 ARO Pistachios Inc. 19750 Avenue 88, Terra Bella, CA 93270
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0398-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 6,180 units of the RapidFlap SpinDown Clamp because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V805000·2018-11-14

    Ford Recalls 2018 Expedition and Lincoln Navigator for Seat Track Defect

    Ford is recalling 2018 Expedition and Lincoln Navigator vehicles because missing seat brackets may allow the second-row center seat to move in a crash, increasing injury risk.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0408-2019·2018-11-14

    NUTRANEXT Toxin Absorber Recalled for Elevated Lead Levels

    NUTRANEXT BUSINESS LLC is recalling Toxin Absorber with Organic Ginger Root packets because routine testing found elevated lead levels.

    Product
    Toxin Absorber with Organic Ginger Root - 14 packets and 30 packets
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0227-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 15mg pellets because the company cannot ensure the products are sterile. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0230-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 6 mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0229-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 25mg pellets because the company cannot assure the sterility of the product. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2019·2018-11-14

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

    Product
    5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2019·2018-11-14

    Silver Star Brands Recalls DizziFree Oral Spray Due to CGMP Deviations

    Silver Star Brands is recalling 247 bottles of Healthful Naturals DizziFree Oral Spray due to manufacturing deviations that could result in microbial contamination.

    Product
    Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 12.5mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2019·2018-11-14

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 2,580,448 bags of 0.9% Sodium Chloride Injection because they may leak and lack assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0405-2019·2018-11-14

    Valley Processing Recalls Apple Juice Concentrate Due to Arsenic Levels

    Valley Processing Inc. is recalling specific lots of apple juice concentrate and organic apple juice concentrate because they contain high levels of inorganic arsenic.

    Product
    Apple juice concentrate and organic apple juice concentrate in 52 gallon drums, 5 gallon pails, 4 gallon pails, and 260 gallon totes
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2019·2018-11-14

    Qualgen Testosterone and Anastrozole Pellets Recalled for Sterility Concerns

    Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets due to a lack of assurance of sterility. The recall affects specific vial sizes distributed nationwide.

    Product
    Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V796000·2018-11-12

    Coach and Equipment Recalls 2015-2018 Phoenix and Metro Lite Buses

    Coach and Equipment is recalling 864 transit buses because foldaway seats may not lock properly, increasing injury risk in crashes.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX, METRO LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V798000·2018-11-12

    Champion and Goshen Transit Buses Recalled for Seat Lock Defect

    Champion Bus is recalling 2017-2018 transit buses because foldaway seats may not stay locked during a crash or sudden stop, increasing injury risk.

    Product
    CHAMPION — CHAMPION, GOSHEN LF TRANSPORT, CHALLENGER, G-FORCE, IMPULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V799000·2018-11-12

    Starcraft Transit Bus Recall for Foldaway Seat Locking Defect

    Forest River is recalling specific Starcraft transit buses because foldaway seat cushions may not stay locked in a crash, increasing injury risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, STARCRAFT SENATOR II, ALLSTAR, STARLITE, STARQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·110-2018·2018-11-09

    NuVue Foods Recalls Chicken Burritos Due to Undeclared Egg Allergen

    NuVue Foods is recalling 18th Street Deli Chicken Burritos because they contain egg, an undeclared allergen. The products were distributed in Indiana, Michigan, and Ohio.

    Product
    NuVue Foods — NuVue Foods Recalls Burrito Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·18V792000·2018-11-09

    Altec Recalls 2017-2018 Aerial Devices Due to Wiring Fire Risk

    Altec is recalling 186 aerial devices from 2017-2018 because under-hood wiring may be damaged by sharp edges, increasing the risk of a fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V794000·2018-11-09

    Terex Recalls 2017-2018 Digger Derrick Vehicles Due to Weld Defect

    Terex is recalling 2017-2018 Digger Derrick vehicles because insufficient welds on the guide bar may cause the guide arm to fall, posing an injury risk to nearby personnel.

    Product
    TEREX — TEREX DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide