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.

22151–22175 of 32121

  • SevereNHTSA·15E076000·2015-09-21

    Henderson Wheel Recalls Torsion Arm Assemblies Due to Detachment Risk

    Henderson Wheel is recalling torsion arm assemblies where the arm is too small for its housing, posing a risk of trailer detachment and loss of control.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3201-2015·2015-09-16

    Jeni's Snowy Coconut Macaroon Ice Cream Sandwich Recalled for Listeria

    Jeni's Splendid Ice Creams is recalling Snowy Coconut Macaroon Ice Cream Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Snowy Coconut Macaroon Ice Cream Sandwich Case, 515, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen. Snowy Coconut Macaroon Ice Cream Sandwich, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3111-2015·2015-09-16

    Jeni's Green Ice Cream Recalled for Listeria Contamination Risk

    Jeni's Splendid Ice Creams LLC is recalling Green Ice Cream products due to potential Listeria monocytogenes contamination. Consumers should discard or return affected items.

    Product
    Green Ice Cream Bucket, 805, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Green Ice Cream Pint Case, 705, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Green Ice Cream Pint, Jeni's…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3218-2015·2015-09-16

    Jeni's Apricot Frozen Yogurt Recalled for Listeria Contamination Risk

    Jeni's Splendid Ice Creams is recalling Apricot Frozen Yogurt pints due to potential Listeria monocytogenes contamination. The recall covers approximately 1.5 million units distributed across 18 U.S. states.

    Product
    Apricot Frozen Yogurt Pint Case, 238, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Apricot Frozen Yogurt Pint, Jenis Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3145-2015·2015-09-16

    Jeni's Milkiest Chocolate Ice Cream Recalled for Listeria Contamination

    Jeni's Splendid Ice Creams is recalling Milkiest Chocolate in the World ice cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.

    Product
    The Milkiest Chocolate in the World Ice Cream Bucket, 325, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. The Milkiest Chocolate in the World Ice Cream Pint Case, 294, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8…
    Category
    Food
    Distribution
    18 states
  • SevereUSDA FSIS·123-2015·2015-09-16

    Di Stefano Cheese Co. Recalls Parma Ham Produced Without Inspection

    Di Stefano Cheese Co. is recalling approximately 1,280 pounds of Parma Boneless Ham produced in Italy that were not presented for U.S. inspection.

    Product
    Di Stefano Cheese Co. Recalls Ham Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3222-2015·2015-09-16

    Jeni's Red Raspberry Sorbet Recalled for Listeria Contamination Risk

    Jeni's Splendid Ice Creams is recalling Red Raspberry Sorbet pints due to potential Listeria monocytogenes contamination. The recall covers approximately 1.5 million units distributed nationally.

    Product
    Red Raspberry Sorbet Pint Case, 286, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Red Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3200-2015·2015-09-16

    Jeni's Smoked Dark Chocolate Macaroon Ice Cream Sandwich Recalled for Listeria

    Jeni's Splendid Ice Creams LLC is recalling Smoked Dark Chocolate Macaroon Ice Cream Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Smoked Dark Chocolate Macaroon Ice Cream Sandwich Case, Jeni's Splendid Ice Creams, LLC, 6-oz sandwich, paper box, 14 boxes per case, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3115-2015·2015-09-16

    Jeni's Whiskey Eggnog Ice Cream Recalled for Listeria Risk

    Jeni's Splendid Ice Creams is recalling Middle West Whiskey Eggnog ice cream due to potential Listeria monocytogenes contamination.

    Product
    Middle West Whiskey Eggnog Ice Cream Bucket, 372, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Middle West Whiskey Eggnog Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3144-2015·2015-09-16

    Jeni's Splendid Ice Creams Recalls Buckeye State Ice Cream Due to Listeria Risk

    Jeni's Splendid Ice Creams LLC is recalling Buckeye State Ice Cream products because they may be contaminated with Listeria monocytogenes.

    Product
    The Buckeye State Ice Cream Bucket, 309, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. The Buckeye State Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. The Buckeye State…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3112-2015·2015-09-16

    Jeni's Intelligentsia Black Cat Espresso Ice Cream Recalled for Listeria

    Jeni's Splendid Ice Creams is recalling Intelligentsia Black Cat Espresso Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Intelligentsia Black Cat Espresso Ice Cream Bucket, 347, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Intelligentsia Black Cat Espresso Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Drugs)·D-1428-2015·2015-09-16

    PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Concerns

    PharMEDium Services is recalling 120 cassettes of Ropivacaine HCl 0.2% due to a reported sterility failure. The affected units were distributed to Virginia, Illinois, Pennsylvania, and Idaho.

    Product
    Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-3140-2015·2015-09-16

    Jeni's Sweet Corn and Black Raspberries Ice Cream Recalled for Listeria

    Jeni's Splendid Ice Creams is recalling Sweet Corn & Black Raspberries ice cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.

    Product
    Sweet Corn & Black Raspberries Ice Cream Bucket, 324, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Corn & Black Raspberries Ice Cream Pint Case, 219, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2485-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3150-2015·2015-09-16

    Jeni's White Chocolate Peppermint Ice Cream Recalled for Listeria Risk

    Jeni's Splendid Ice Creams is recalling White Chocolate Peppermint ice cream products due to potential Listeria monocytogenes contamination.

    Product
    White Chocolate Peppermint Ice Cream Bucket, 375, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. White Chocolate Peppermint Pint Case, 275, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. White…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3213-2015·2015-09-16

    Jeni's Eggnog Special Pint Recalled for Listeria Contamination

    Jeni's Splendid Ice Creams LLC is recalling Eggnog Special Pints due to potential Listeria monocytogenes contamination. Consumers should discard the product.

    Product
    Eggnog Special Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3193-2015·2015-09-16

    Jeni's Guava Buttermilk Frozen Yogurt Sandwich Recalled for Listeria Risk

    Jeni's Splendid Ice Creams is recalling Guava Buttermilk Frozen Yogurt Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Guava Buttermilk Frozen Yogurt Sandwich Case, 507, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, 14 boxes per case, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3158-2015·2015-09-16

    Jeni's Banana French Toast Ice Cream Recalled for Listeria Risk

    Jeni's Splendid Ice Creams is recalling Banana French Toast ice cream products due to potential contamination with Listeria monocytogenes.

    Product
    Banana French Toast Bucket, 354, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Banana French Toast Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Banana French Toast Pint…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3102-2015·2015-09-16

    Jeni's Cherry Lambic Ice Cream Recalled for Listeria Contamination

    Jeni's Splendid Ice Creams LLC is recalling Cherry Lambic ice cream products due to potential Listeria monocytogenes contamination.

    Product
    Cherry Lambic Ice Cream Bucket, 328, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cherry Lambic Ice Cream Pint Case, 228, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cherry Lambic Ice…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2754-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers

    Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3209-2015·2015-09-16

    Jeni's Splendid Ice Creams Recalls Mini Orchid Vanilla Macaroon Sandwiches

    Jeni's Splendid Ice Creams LLC is recalling Mini Orchid Vanilla Macaroon Sandwiches due to potential Listeria monocytogenes contamination. The recall covers approximately 16,814 units distributed nationally.

    Product
    Mini Orchid Vanilla Macaroon Case, Jenis Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen, 7 sandwiches per sleeve, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3204-2015·2015-09-16

    Jeni's Ohio Maple Brittle Ice Cream Recalled for Listeria Risk

    Jeni's Splendid Ice Creams LLC is recalling Ohio Maple Brittle Ice Cream half-gallon containers due to potential Listeria monocytogenes contamination.

    Product
    Ohio Maple Brittle Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-3095-2015·2015-09-16

    Jeni's Ice Cream Recalled for Potential Listeria Contamination

    Jeni's Splendid Ice Creams is recalling specific Milk Chocolate Bombay ice cream products due to potential Listeria monocytogenes contamination.

    Product
    Milk Chocolate Bombay N.3 Ice Cream Bucket, 364, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bombay, Milk Chocolate Ice Cream Pint Case, 264, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2484-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3148-2015·2015-09-16

    Jeni's Whiskey & Pecans Ice Cream Recalled for Listeria Risk

    Jeni's Splendid Ice Creams is recalling Whiskey & Pecans ice cream in 3-gallon buckets and pints due to potential Listeria monocytogenes contamination.

    Product
    Whiskey & Pecans Ice Cream Bucket, 335, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Whiskey & Pecans Ice Cream Pint Case, 234, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Whiskey & Pecans…
    Category
    Food
    Distribution
    18 states