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.

22651–22675 of 32171

  • SevereFDA (Food)·F-1523-2015·2015-07-08

    Snoqualmie Mango Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Mango 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-1522-2015·2015-07-08

    Snoqualmie Mango Passion Fruit Sorbet Recalled for Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Mango Passion Fruit Sorbet due to contamination with Listeria monocytogenes. The product was distributed nationwide.

    Product
    Mango Passion Fruit Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs, in addition to a quantity of unknown sizes. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1198-2015·2015-07-08

    Lincare Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific lots of Potassium Chloride IV bags because the sterility of the product is not assured.

    Product
    Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 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 (Drugs)·D-1175-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil 1200mg IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 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-1475-2015·2015-07-08

    Snoqualmie Double Chocolate Custard with Espresso Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Double Chocolate Custard with Espresso due to potential Listeria monocytogenes contamination.

    Product
    Double Chocolate Custard with Espresso, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1161-2015·2015-07-08

    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, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1189-2015·2015-07-08

    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. The recall affects units distributed in Arkansas.

    Product
    Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 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 (Drugs)·D-1174-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil 4800mg IV bags compounded in Arkansas because the sterility of the product is not assured.

    Product
    Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 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 (Drugs)·D-1163-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

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

    Product
    TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1168-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

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

    Product
    Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, 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 (Drugs)·D-1152-2015·2015-07-08

    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, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1166-2015·2015-07-08

    Lincare Recalls Penicillin G Potassium IV Bags Due to Sterility Concerns

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

    Product
    Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 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 (Devices)·Z-1894-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1201-2015·2015-07-08

    Lincare Recalls Ceftazidime IV Bags Due to Sterility Concerns

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

    Product
    Ceftazidime 2 gm / NS 50mL, Qty: 15 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 (Drugs)·D-1170-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

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

    Product
    Fluorouracil 1400mg / D5W 278mL Qty: 1 278 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-1502-2015·2015-07-08

    Snoqualmie Coconut Pineapple Sorbet Recalled for Listeria Risk

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

    Product
    Coconut Pineapple Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1182-2015·2015-07-08

    Lincare Recalls Compounded Vancomycin and Heparin Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Vancomycin and Heparin products because the sterility of the product is not assured. The recall affects products distributed in Arkansas.

    Product
    VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, 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-1469-2015·2015-07-08

    Snoqualmie Cherry Vanilla Custard Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Cherry Vanilla Custard (without egg) due to potential Listeria monocytogenes contamination.

    Product
    Cherry Vanilla Custard (without egg), sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1153-2015·2015-07-08

    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, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1480-2015·2015-07-08

    Snoqualmie French Vanilla Custard Recalled for Listeria monocytogenes

    Snoqualmie Gourmet Ice Cream is recalling French Vanilla Custard due to the presence of Listeria monocytogenes. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    French Vanilla Custard (with soy lecithin), sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1197-2015·2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin 1000mg IV bags compounded by United Medical IV Center in Arkansas because the sterility of the product is not assured.

    Product
    Vancomycin 1000mg / NS 100mL, Packaged in 100 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-1532-2015·2015-07-08

    Snoqualmie Pear Champagne Sorbet Recalled for Listeria Risk

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

    Product
    Pear Champagne Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1499-2015·2015-07-08

    Snoqualmie Blueberry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Blueberry Sorbet due to the potential for Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Blueberry 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-1542-2015·2015-07-08

    Snoqualmie Raspberry Sorbet Recalled for Potential Listeria Contamination

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

    Product
    Raspberry 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 (Drugs)·D-1186-2015·2015-07-08

    Lincare Recalls Vancomycin HCl / Heparin Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl / Heparin compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, 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