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.

15001–15025 of 29202

  • SevereNHTSA·18V069000·2018-01-26

    Mitsubishi Recalls Vehicles Due to Drive Belt Tensioner Flange Crack Risk

    Mitsubishi is recalling specific 2008-2012 models because a cracked drive belt tensioner flange may cause the belt to detach, leading to engine stalling and increased crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, LANCER, OUTLANDER SPORT, LANCER SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V071000·2018-01-26

    Mitsubishi Recalls Vehicles Due to Sunroof Glass Detachment Risk

    Mitsubishi is recalling specific 2007-2010 models because the sunroof glass may detach and become a road hazard, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI LANCER SPORTBACK, LANCER EVOLUTION, LANCER, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V070000·2018-01-26

    Mitsubishi Recalls Outlander Models for Parking Brake Corrosion Risk

    Mitsubishi is recalling 2013-2016 Outlander and Outlander Sport vehicles because water may cause parking brake parts to corrode and bind, potentially preventing the brake from engaging.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V068000·2018-01-25

    Honda Recalls 2017 Clarity Fuel Cell Vehicles for Power Loss Risk

    Honda is recalling 2017 Clarity Fuel Cell vehicles because a software defect may cause reduced or complete power loss, increasing crash risk.

    Product
    HONDA — HONDA CLARITY FUEL CELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2018·2018-01-24

    Rugby Aller-chlor Syrup Recalled for Microbial Contamination

    Pharmatech LLC is recalling Rugby Aller-chlor syrup due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0569-2018·2018-01-24

    Bellisio Michelina's Fettuccine Alfredo Recalled for Undeclared Soy

    Bellisio Foods is recalling Michelina's Fettuccine Alfredo packages due to undeclared soy. The recall follows a consumer report of chicken in the product, which contains soy.

    Product
    Michelina's Fettuccine Alfredo NET WT. 8.5 oz package Frozen CONTAINS MILK, WHEAT BELLISIO FOODS, INC., DULUTH, MN 55802 UPC 7 17854 10501 9
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0579-2018·2018-01-24

    Polly Ann Red Bean Ice Cream Bar Recalled for Undeclared Milk Allergen

    California Popsicle, Inc. is recalling Polly Ann Red Bean Ice Cream Bars because they contain undeclared milk, a major food allergen.

    Product
    Polly Ann Red Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26868 7
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0380-2018·2018-01-24

    RayStation 6 Proton QA Module Recall for Potential Dosage Errors

    RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.

    Product
    RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2018·2018-01-24

    Merge Healthcare Recalls Power Strips in Hemo System Due to Overheating

    Merge Healthcare is recalling 1,150 power strips sold with the Merge Hemo System because an input resistor can overheat and cause the unit to smoke.

    Product
    Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2018·2018-01-24

    Rugby Diocto Syrup Recalled for Microbial Contamination

    Pharmatech LLC is recalling Rugby Diocto Syrup due to microbial contamination, including the presence of yeast and potential B. cepacia.

    Product
    Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0224-2018·2018-01-24

    Rugby Diocto Liquid Recalled for Microbial Contamination

    PharmaTech LLC is recalling Rugby Diocto Liquid due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0221-2018·2018-01-24

    Pharmedium Recalls Superpotent Phenylephrine Syringes Nationwide

    Pharmedium Services is voluntarily recalling 2,390 syringes of Phenylephrine HCL 100 mcg/mL due to a superpotent drug classification.

    Product
    Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0580-2018·2018-01-24

    Polly Ann Mango Ice Cream Bar Recalled for Undeclared Milk Allergen

    California Popsicle, Inc. is recalling Polly Ann Mango Ice Cream Bars due to an undeclared milk allergen. The product was distributed in New York, California, and Canada.

    Product
    Polly Ann Mango Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 28866 1
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0226-2018·2018-01-24

    Rugby Senexon Liquid Recalled for Microbial Contamination

    Pharmatech LLC is recalling Rugby Senexon Liquid due to microbial contamination, including yeast and potential B. cepacia.

    Product
    Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0353-2018·2018-01-24

    Zoll LifeVest Wearable Defibrillator Recalled for Defibrillation Shock Failure Risk

    Zoll Manufacturing Corp. is recalling 33,670 LifeVest Wearable Defibrillators due to an incorrect service code that may prevent the device from detecting critical defects, potentially leading to defibrillation shock failure.

    Product
    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V064000·2018-01-22

    Suzuki Recalls 2017-2018 GSX-R1000 Motorcycles for Chain Break Risk

    Suzuki is recalling 2017-2018 GSX-R1000 motorcycles because a gear shift error can cause the drive chain to break, leading to power loss and crash risk.

    Product
    SUZUKI — SUZUKI GSX-R1000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0159-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 130,740 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0638-2018·2018-01-17

    Jack Brown Produce Recalls Fuji Apples for Listeria Contamination Risk

    Jack Brown Produce is voluntarily recalling Fuji apples due to potential Listeria monocytogenes contamination reported by a supplier.

    Product
    Fuji, whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0639-2018·2018-01-17

    Jack Brown Produce Recalls Golden Delicious Apples Due to Listeria Risk

    Jack Brown Produce is voluntarily recalling Golden Delicious apples due to potential Listeria monocytogenes contamination. The recall affects specific lots distributed in five US states.

    Product
    Golden Delicious whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0618-2018·2018-01-17

    Nyblad Orchards Recalls Fuji Apples Due to Listeria Risk

    Nyblad Orchards is voluntarily recalling Fuji apples due to potential Listeria monocytogenes contamination. The recall covers various package sizes distributed in Michigan.

    Product
    Fuji, whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic container boxes " 50ct, individual…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0208-2018·2018-01-17

    Teva Recalls Moexipril Hydrochloride Tablets Due to Impurity Test Failure

    Teva Pharmaceuticals is recalling specific bottles of Moexipril Hydrochloride and Hydrochlorothiazide tablets because routine stability testing found high levels of a degradation impurity.

    Product
    Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0640-2018·2018-01-17

    Jack Brown Produce Recalls Apples Due to Listeria Risk

    Jack Brown Produce is voluntarily recalling multiple varieties of apples because they may be contaminated with Listeria monocytogenes.

    Product
    Golden Del., Gala, Fuji, Honey Crisp; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0619-2018·2018-01-17

    Nyblad Orchards Recalls Fresh Apples Due to Listeria Risk

    Nyblad Orchards is voluntarily recalling multiple varieties of fresh apples due to potential contamination with Listeria monocytogenes.

    Product
    Gala, Fuji., honey crisp, golden delicious whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0212-2018·2018-01-17

    Pfizer Recalls Atorvastatin Tablets Due to Microbial Contamination

    Pfizer is recalling specific export-only batches of atorvastatin calcium tablets due to microbial contamination. No product was distributed in the United States.

    Product
    FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
    Category
    Drug
    Distribution
    0 states