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.

20001–20025 of 32117

  • SevereNHTSA·16V455000·2016-06-22

    Winnebago Recalls 2014-2016 Motorhomes Due to Throttle Sensor Defect

    Winnebago is recalling 2014-2016 Tour and Itasca Ellipse motorhomes because a throttle sensor defect may prevent the engine brake from activating, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA TOUR, ELIPSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1896-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2016·2016-06-22

    Hospira Recalls Vancomycin Hydrochloride Injection Due to Cardboard Particulate Matter

    Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection due to the presence of cardboard particulate matter.

    Product
    Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1893-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1895-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1485-2016·2016-06-22

    Fresh Express Chopped Asian Salad Recalled for Undeclared Allergens

    Fresh Express is recalling Chopped Asian salad bowls due to undeclared wheat, soy, and tree nuts (almonds). The product was distributed in Pennsylvania.

    Product
    The Farmers Market, Chopped Asian, Chopped Lettuce Blend, Roasted Chicken, Cherry Infused Cranberries & Almond Crunch, Square Noodles and Sesame Ginger Dressing, Net Wt. 6.25 oz. (177g), packed in clear rigid plastic containers, Fresh Express Incorporated, P.O. Box 80599…
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V450000·2016-06-21

    Forest River Recalls 2016-2017 Flagstaff and Work N' Play Trailers

    Forest River is recalling 2016-2017 Flagstaff and Work N' Play trailers because a propane regulator sight glass may crack, allowing gas to leak and potentially cause a fire.

    Product
    FOREST RIVER — FOREST RIVER FLAGSTAFF, WORK AND PLAY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V452000·2016-06-21

    Navistar Recalls 2016 IC Bus RE School Buses for Seat Defect

    Navistar is recalling 2016 IC Bus RE school buses because child seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    IC BUS — IC BUS RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16199·2016-06-21

    Tommee Tippee Electric Bottle and Food Warmers Recalled for Fire Hazard

    Mayborn USA is recalling about 255,000 Tommee Tippee electric bottle and food warmers due to a fire hazard. The units can overheat, melt, smoke, and catch fire.

    Product
    Electric bottle and food warmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·052-2016·2016-06-20

    U.S. Cado Holdings Recalls Imported Swai Fillets for Regulatory Violations

    U.S. Cado Holdings is recalling approximately 25,760 pounds of imported frozen Swai fillets that entered U.S. commerce without meeting FSIS residue testing requirements.

    Product
    U.S. Cado Holdings, Inc. Recalls Imported Siluriformes Fish Products Distributed Without Meeting FSIS Requirements
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·16V447000·2016-06-20

    Eldorado Shuttle Buses Recalled for Electrical Component Fire Risk

    Eldorado is recalling 2016 Aerotech, Aero Elite, and Advantage shuttle buses because a component in the electrical power distribution center may break, causing electrical arcing and increasing the risk of fire.

    Product
    ELDORADO — ELDORADO ADVANTAGE, AEROTECH, AERO ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·051-2016·2016-06-18

    GNP Company Recalls Chicken Products Due To Foreign Matter Contamination

    GNP Company is recalling approximately 55,608 pounds of chicken products that may be contaminated with sand and black soil. No illnesses have been reported.

    Product
    Pilgrim's Pride Corporation — GNP Company Recalls Chicken Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·050-2016·2016-06-17

    Red Bowl Wonton and Dumpling Products Recalled for Undeclared Egg Allergen

    Red Bowl Foods is recalling wonton and dumpling products because they contain egg, a known allergen, that is not declared on the label.

    Product
    Red Bowl Food Corporation — Red Bowl Food Corporation Recalls Wonton and Dumpling Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V441000·2016-06-16

    Eldorado Amerivan 10 Recall for Fuel Line Leak Fire Risk

    Eldorado is recalling 2012-2016 Amerivan 10 vehicles because an improperly installed fuel line may leak and cause a fire.

    Product
    ELDORADO — ELDORADO AMERIVAN 10
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1010-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #4 because FDA inspections found violations that may affect sterility.

    Product
    SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1025-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #3 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product sterility.

    Product
    QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0965-2016·2016-06-15

    FDA Recalls Thin and Slim Burn Fat Now Supplement for Unapproved Ingredient

    Novacare, LLC is recalling Thin and Slim Burn Fat Now dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.

    Product
    Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0988-2016·2016-06-15

    FDA Recalls 1-HCG 1000 IU/ML Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML vials because FDA inspections identified GMP violations that may impact product sterility.

    Product
    1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0958-2016·2016-06-15

    Baxter Recalls Dextrose Injection Due to Insect Contamination

    Baxter Healthcare is recalling Dextrose Injection, USP, 70% due to confirmed reports of an insect found in the primary container.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0963-2016·2016-06-15

    FDA Recalls MaxOut Body Fat Burner for Unapproved Salicylic Acid

    Novacare, LLC is recalling MaxOut Body Fat Burner with Ephedra because FDA sampling confirmed the presence of salicylic acid in the dietary supplement.

    Product
    Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1006-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #1 vials because FDA inspections found violations that may affect sterility.

    Product
    QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V440000·2016-06-15

    Mercedes-Benz Recalls 2016 GLE450 Vehicles Due to Engine Shutdown Risk

    Mercedes-Benz is recalling 5,826 model year 2016 GLE450 vehicles because a software error may cause the engine to shut down while braking, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0984-2016·2016-06-15

    Estradiol Valerate Recall Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state