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.

28751–28775 of 32252

  • SevereFDA (Drugs)·D-154-2013·2013-02-13

    Hospira Recalls Carboplatin Injection Vials Due to Visible Crystals

    Hospira is recalling 31,326 vials of Carboplatin Injection due to visible crystals found during inspection. The product is distributed nationwide and in Puerto Rico.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-147-2013·2013-02-13

    Mylan Recalls Lansoprazole Capsules Due to Foreign Topiramate Tablets

    Mylan Pharmaceuticals is recalling 1,894 bottles of lansoprazole 30 mg capsules because they may contain foreign topiramate 100 mg tablets.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-153-2013·2013-02-13

    Hospira Recalls Carboplatin Injection Vials Due to Crystallization

    Hospira Inc. is recalling 23,315 vials of Carboplatin Injection due to visible particulates identified as Carboplatin crystals.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0777-2013·2013-02-13

    Winco Premier Lifecare Recliner 5400 Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Premier Lifecare Recliner 5400 units because their foam and vinyl do not meet California's TB 133 fire protection standards.

    Product
    PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-158-2013·2013-02-13

    Bracco Recalls Isovue-300 Injection Syringes Due to Particulate Matter

    Bracco Diagnostic Inc. is recalling specific lots of Isovue-300 Injection syringes because they contain particulate matter identified as cellulose and polyvinyl fibers.

    Product
    Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-155-2013·2013-02-13

    Zicam Nasal Spray Recalled for Burkholderia cepacia Contamination

    Matrixx Initiatives Inc is recalling Zicam Extreme Congestion Relief nasal spray due to potential contamination with Burkholderia cepacia. The recall covers 46,752 bottles distributed nationwide.

    Product
    Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V046000·2013-02-11

    Spartan Recalls Aerial Vehicles Due to Inclinometer Signal Failure

    Spartan is recalling 2005-2011 RMP 100 and 2008-2010 MMP 100 aerial vehicles because a faulty inclinometer may allow the platform to tilt dangerously, risking injury or property damage.

    Product
    SPARTAN — SPARTAN RMP 100, MMP 100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V042000·2013-02-08

    Fontaine Modified Navistar Trucks Recalled for Steering Assembly Defect

    Fontaine Modification is recalling 811 modified Navistar trucks because steering clips may come loose, potentially making the vehicle difficult to steer and increasing crash risk.

    Product
    FONTAINE — FONTAINE INT'L 7400 W/DUAL STEERIN, INT'L 4300 W/DUAL STEERIN, INT'L 4400 W/DUAL STEERIN, INT'L 7500 W/DUAL STEERIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V039000·2013-02-07

    Prevost Recalls Coaches Due to Throttle Control Software Defect

    Prevost is recalling specific model year 2008-2013 coaches equipped with Volvo engines because a software defect may cause the throttle to remain fixed at 1700 rpm, increasing crash risk.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, H3-45, X3-45, H3-41
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13117·2013-02-07

    BlueStar Residential Gas Wall Ovens Recalled for Fire Hazard

    Prizer Painter Stove Works is recalling about 940 BlueStar gas wall ovens due to a fire hazard caused by improper installation or damaged gas connectors.

    Product
    BlueStar™ residential gas wall ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V045000·2013-02-07

    BMW Recalls 2007-2010 X5 Vehicles Due to Brake Vacuum Pump Leak

    BMW is recalling 2007-2010 X5 SAVs with 8-cylinder engines because a brake vacuum pump leak may cause loss of power assist braking, increasing stopping distance.

    Product
    BMW — BMW X5 SAV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13723·2013-02-07

    BRP Recalls Ski-Doo Snowmobiles Due to Fuel Leak Fire Hazard

    Bombardier Recreational Products is recalling about 10,200 Ski-Doo snowmobiles because a fuel pump fitting can break, causing a fuel leak and fire hazard.

    Product
    Ski-Doo® snowmobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0947-2013·2013-02-06

    Island Delights Coconut Haystacks Recalled for Missing Milk Allergen Labeling

    Island Delights is recalling specific lots of Almond Natural Flavor Coconut Haystacks because the ingredient list failed to disclose the presence of milk.

    Product
    Island Delights ALMOND Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc., Seville, OH 44273"
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-0963-2013·2013-02-06

    Dymatize Elite Protein Bars Recalled for Peanut Allergen Mislabeling

    Belmont Confections is recalling Dymatize Elite Gourmet Cookies & Cream protein bars because they contain peanuts but do not list them on the label.

    Product
    DYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0948-2013·2013-02-06

    Kinnikinnick Frozen Pie Crusts Recalled for Undeclared Egg Allergen

    Jerusalem Manufacturing Natural Foods & Wholesalers, Inc. is recalling Kinnikinnick Foods Brand Frozen Pie Crusts because egg is not declared on the label.

    Product
    Kinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0960-2013·2013-02-06

    United Natural Foods Recalls Kinnikinnick Pie Crust Due to Allergy Alert

    United Natural Foods is recalling Kinnikinnick Pie Crust in six states due to an expanded allergy alert issued by the manufacturer.

    Product
    Kinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0949-2013·2013-02-06

    Kinnikinnick Pie Crusts Recalled for Undeclared Egg Allergen

    Unified Grocers is recalling Kinnikinnick Pie Crusts because they contain undeclared egg allergen.

    Product
    Kinnikinnick Foods Pie Crusts, 10.2 oz, Item code: 21-35265, UPC 6-20133-00600.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0945-2013·2013-02-06

    Island Delights Coconut Haystacks Recalled for Missing Milk Allergen Labeling

    Island Delights, Inc. is recalling specific lots of Coconut Haystacks because the ingredient list failed to disclose milk, a major food allergen.

    Product
    Island Delights Almond Chocolate/Almond Mix Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL ALMOND FLAVOR***Island Delights, Inc., Seville, OH 44273"
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0754-2013·2013-02-06

    GE AdvantageSim MD Software Recall for Incorrect Series Labeling

    GE Healthcare is recalling AdvantageSim MD versions 7.4 through 7.6 because incorrect series labeling may lead to under-treatment of tumors.

    Product
    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-0946-2013·2013-02-06

    Island Delights Coconut Haystacks Recalled for Undeclared Milk Allergen

    Island Delights is recalling Coconut Haystacks because the ingredient list fails to declare milk, a major food allergen.

    Product
    Island Delights COFFEE NATURAL Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc. Seville, OH 44273"
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0741-2013·2013-02-06

    Hamilton T1 Ventilator Recall for Pediatric Software Calculation Error

    Hamilton Medical Inc is recalling 97 Hamilton T1 ventilators with software versions 1.1.2 or lower due to a calculation error affecting oxygen consumption estimates for small pediatric patients.

    Product
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V038000·2013-02-06

    Chrysler Recalls Trucks Due to Rear Axle Pinion Nut Loosening Risk

    Chrysler is recalling specific 2009-2012 Ram 1500, Dodge Dakota, Durango, and Chrysler Aspen trucks because the rear axle pinion nut may loosen, potentially causing a loss of vehicle control.

    Product
    DODGE — DODGE, CHRYSLER DAKOTA, RAM 1500, DURANGO, ASPEN
    Category
    Vehicle
    Distribution
    Distributed nationwide