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.

22601–22625 of 32171

  • SevereFDA (Drugs)·D-1187-2015·2015-07-08

    Lincare Recalls Fentanyl Citrate IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fentanyl Citrate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1504-2015·2015-07-08

    Snoqualmie Coconut Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Coconut Sorbet due to the potential for Listeria monocytogenes contamination.

    Product
    Coconut Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1551-2015·2015-07-08

    Snoqualmie Watermelon Sorbet Recalled for Listeria Contamination Risk

    Snoqualmie Gourmet Ice Cream is recalling Watermelon Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.

    Product
    Watermelon Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1461-2015·2015-07-08

    Snoqualmie 19% Ice Cream Mix Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling 19% Ice Cream Mix due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 2.5 gallon bags.

    Product
    19% Ice Cream Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2015·2015-07-08

    Lincare Recalls TPN 2:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 2:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1160-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes Calcium Gluc, Na Phos, Na Acetate, MgSO4, K Acetate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Folic Acid, Rx Only. Compounded by…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1164-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1524-2015·2015-07-08

    Snoqualmie Mixed Berry Sorbet Recalled for Listeria Contamination Risk

    Snoqualmie Gourmet Ice Cream is recalling Mixed Berry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in various plastic containers.

    Product
    Mixed Berry Sorbet, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays, 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1521-2015·2015-07-08

    Snoqualmie Mandarine/Tangerine Sorbet Recalled for Listeria Contamination Risk

    Snoqualmie Gourmet Ice Cream is recalling Mandarine/Tangerine Sorbet due to potential Listeria monocytogenes contamination.

    Product
    Mandarine/Tangerine Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1462-2015·2015-07-08

    Snoqualmie Chocolate Ice Cream Mix Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling 5.5% Chocolate Ice Cream Mix due to potential Listeria monocytogenes contamination.

    Product
    5.5% Chocolate Ice Cream Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1503-2015·2015-07-08

    Snoqualmie Coconut Rum Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Coconut Rum Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Coconut Rum Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1185-2015·2015-07-08

    Lincare Recalls Ciprofloxacin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Ciprofloxacin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1554-2015·2015-07-08

    Snoqualmie Chocolate Gelato Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling 1.5-gallon tubs of Chocolate Gelato due to potential Listeria monocytogenes contamination.

    Product
    Chocolate Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1552-2015·2015-07-08

    Snoqualmie Almond Buttercrunch Toffee Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Almond Buttercrunch Toffee Gelato due to potential Listeria monocytogenes contamination.

    Product
    Almond Buttercrunch Toffee Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1559-2015·2015-07-08

    Snoqualmie Gianduja Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Gianduja Gelato due to potential Listeria monocytogenes contamination.

    Product
    Gianduja Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1169-2015·2015-07-08

    Lincare Recalls Ceftriaxone Sodium Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Ceftriaxone Sodium IV bags because the sterility of the product is not assured.

    Product
    CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1528-2015·2015-07-08

    Snoqualmie Passion Fruit Sorbet Recalled for Listeria Contamination Risk

    Snoqualmie Gourmet Ice Cream is recalling Passion Fruit Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.

    Product
    Passion Fruit Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1917-2015·2015-07-08

    HeartWare Ventricular Assist System Recalled for Power Switching Issues

    HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.

    Product
    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Drugs)·D-1184-2015·2015-07-08

    Lincare Recalls Cefepime IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling 3 bags of Cefepime 1gm/NS 50mL AccuFlo compounded in Little Rock, Arkansas, because the sterility of the product is not assured.

    Product
    CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1540-2015·2015-07-08

    Snoqualmie Pomegranate Cranberry Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Pomegranate Cranberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Pomegranate Cranberry Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1569-2015·2015-07-08

    Snoqualmie Rosewater Pistachio Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Rosewater Pistachio Gelato due to potential Listeria monocytogenes contamination.

    Product
    Rosewater Pistachio Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1458-2015·2015-07-08

    Snoqualmie 14% Special Ice Cream Mix Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling 14% Special Ice Cream Mix due to potential Listeria monocytogenes contamination.

    Product
    14% Special Ice Cream Mix (without soy lecithin), sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1485-2015·2015-07-08

    Snoqualmie Lemon Perfection Custard Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Lemon Perfection Custard due to potential Listeria monocytogenes contamination. The product was distributed nationwide in various sizes.

    Product
    Lemon Perfection Custard, sold under Snoqualmie brand. Product is sold in 16 oz. (pint) paper cartons;1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1535-2015·2015-07-08

    Snoqualmie Pineapple Basil Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Pineapple Basil Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Pineapple Basil Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1511-2015·2015-07-08

    Snoqualmie Guava Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Guava Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Guava Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide