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.

22551–22575 of 32171

  • SevereFDA (Devices)·Z-1902-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1553-2015·2015-07-08

    Snoqualmie Chocolate Brilliance Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Chocolate Brilliance Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Chocolate Brilliance Gelato, 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-1561-2015·2015-07-08

    Snoqualmie Honey Raspberry Gelato Recalled for Listeria Risk

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

    Product
    Honey Raspberry Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2015·2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl in Dextrose IV bags because the sterility of the product is not assured. The affected bags were compounded in Arkansas.

    Product
    Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 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-1505-2015·2015-07-08

    Snoqualmie Cranberry Orange Sorbet Recalled for Listeria Risk

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

    Product
    Cranberry Orange Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1520-2015·2015-07-08

    Snoqualmie Lime Sorbet Recalled for Potential Listeria Contamination

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

    Product
    Lime Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1190-2015·2015-07-08

    Lincare Recalls Diphenhydramine Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Diphenhydramine HCl syringes because the sterility of the product is not assured.

    Product
    Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, 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-1183-2015·2015-07-08

    Lincare Recalls Deferoxamine Mesylate IV Bags Due to Sterility Concerns

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

    Product
    DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 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-1156-2015·2015-07-08

    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, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1529-2015·2015-07-08

    Snoqualmie Peach Champagne Sorbet Recalled for Listeria Contamination Risk

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

    Product
    Peach Champagne Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs, in addition to a number of unknown sizes. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1568-2015·2015-07-08

    Snoqualmie Ice Cream Recalls Raspberry Gelato for Listeria Risk

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

    Product
    Raspberry 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-1550-2015·2015-07-08

    Snoqualmie Strawberry Sorbet Recalled for Potential Listeria Contamination

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

    Product
    Strawberry Sorbet, 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-1155-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific TPN 3:1 bags because their sterility is not assured. The affected products were compounded in May 2015 and distributed in Arkansas.

    Product
    TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1549-2015·2015-07-08

    Snoqualmie Strawberry Rhubarb Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Strawberry Rhubarb Sorbet due to potential Listeria monocytogenes contamination.

    Product
    Strawberry Rhubarb Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1484-2015·2015-07-08

    Snoqualmie Lemon Custard Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Lemon Custard due to the potential for Listeria monocytogenes contamination.

    Product
    Lemon Custard, 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-1488-2015·2015-07-08

    Snoqualmie Coffee Custard Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Turkish Coast Coffee Custard due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1-gallon trays.

    Product
    Turkish Coast Coffee Custard, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1203-2015·2015-07-08

    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 4250mg / D5W 285mL, Qty: 1 285 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-1513-2015·2015-07-08

    Snoqualmie Lavender Sorbet Recalled for Potential Listeria Contamination

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

    Product
    Lavender Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1188-2015·2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

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

    Product
    Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 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 (Drugs)·D-1205-2015·2015-07-08

    Lincare Recalls Gentamicin Sulfate Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling Gentamicin Sulfate syringes compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, 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
  • SevereCPSC·15176·2015-07-08

    Barnett Outdoors Recalls Black Widow Slingshots Due to Injury Risk

    Barnett Outdoors is recalling Black Widow slingshots because the wrist strap can slip off, causing the slingshot to snap back and strike the user.

    Product
    Sports and hunting slingshots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1467-2015·2015-07-08

    Snoqualmie Checkered Chocolate Custard Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Checkered Chocolate Custard due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs and 16-ounce cartons.

    Product
    Checkered Chocolate Custard, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tub and 16 oz. (pint) paper cartons. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1564-2015·2015-07-08

    Snoqualmie Peppermint Stick Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Peppermint Stick Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Peppermint Stick (with lecithin) Gelato, sold under Snoqualmie Ice Cream 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-1517-2015·2015-07-08

    Snoqualmie Lemon Sorbet Recalled for Potential Listeria Contamination

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

    Product
    Lemon Sorbet, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays and 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide