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.

26376–26400 of 32215

  • SevereNHTSA·14V010000·2014-01-16

    Aston Martin Recalls Multiple Models Due to Accelerator Pedal Arm Defect

    Aston Martin is recalling specific 2008-2014 models because a manufacturing error may cause the accelerator pedal arm to break, preventing the driver from maintaining or increasing engine speed.

    Product
    ASTON MARTIN — ASTON MARTIN V8 VANTAGE S, RAPIDE S, V12 VANTAGE COUPE, DB9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0650-2014·2014-01-15

    Nova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage

    Nova Biomedical is recalling hospital blood glucose meters due to battery swelling and cell leakage. The recall covers approximately 200,000 units distributed nationwide.

    Product
    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0654-2014·2014-01-15

    Anspach Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems from the market because the outer hose on the motor hand-piece can rupture without warning if air flow is blocked.

    Product
    ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1645-2013·2014-01-15

    Creole Bisque Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Creole & Company is recalling Creole Bisque because it contains milk, soy, and wheat without an ingredient statement declaring their presence.

    Product
    Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1380-2014·2014-01-15

    ANAT Recalls Tribulus Supreme 2.0 Supplements Due to Chloramphenicol Contamination

    ANAT, LLC is recalling IMT Wellness Tribulus Supreme 2.0 dietary supplements due to potential chloramphenicol contamination. The product was distributed in Connecticut.

    Product
    IMT Wellness Tribulus Supreme 2.0** GI & Immune Support ** Dietary Supplements 60 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-401-2014·2014-01-15

    Triple Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0683-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Drugs)·D-402-2014·2014-01-15

    FDA Recalls PGE Injectable Due to Sterility Assurance Concerns

    The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL and 40 mcg/mL injectables due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1382-2014·2014-01-15

    Innovative Labs Recalls Terrain Zyme LGS-Zyme Dietary Supplement

    Innovative Labs, LLC is recalling Terrain Zyme LGS-Zyme dietary supplements due to the presence of Chloramphenicol, an antimicrobial agent.

    Product
    Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·003-2014·2014-01-15

    Cloverdale Foods Recalls Beef Franks Due to Undeclared Milk Allergen

    Cloverdale Foods is recalling approximately 2,664 pounds of beef franks because the label fails to declare milk, a known allergen. No adverse reactions have been reported.

    Product
    Cloverdale Foods Co. — North Dakota Firm Recalls Beef Franks Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1381-2014·2014-01-15

    Innovative Labs Recalls Terrain Zyme Myco-Zyme Due to Chloramphenicol

    Innovative Labs, LLC is recalling Terrain Zyme Myco-Zyme dietary supplements because they contain Chloramphenicol, an antimicrobial agent.

    Product
    Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0679-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Drugs)·D-397-2014·2014-01-15

    Watson Recalls Carisoprodol Tablets Due to Metal Particulates

    Watson Laboratories is recalling 4,439 bottles of Carisoprodol Tablets because metal particulates were visually observed in the tablets.

    Product
    Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-403-2014·2014-01-15

    FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns

    The FDA is recalling all lots of Super Triple Mix Injectable from The Compounding Center at Blue Ridge due to quality control concerns regarding sterility assurance.

    Product
    Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-405-2014·2014-01-15

    FDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine injections due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-404-2014·2014-01-15

    Quad Mix Injectable Recalled Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0694-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0631-2014·2014-01-15

    Anspach BLACKMAX-N Pneumatic Motor Recalled for CJD Exposure Risk

    The Anspach Effort, Inc. is recalling four BLACKMAX-N pneumatic motors and one Autolube III foot control used in a case involving a patient with Creutzfeldt-Jacob Disease.

    Product
    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0611-2014·2014-01-15

    Puritan Bennett 840 Ventilator Software Recall for Diagnostic Code XB0069

    Covidien is recalling Puritan Bennett 840 ventilators with specific software revisions because a software error causes the device to stop mechanical ventilation.

    Product
    Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·14079·2014-01-14

    SRAM Recalls Hydraulic Bicycle Brakes Due to Crash and Injury Hazards

    SRAM is recalling about 25,350 hydraulic road rim and disc brakes for bicycles because the systems can fail, posing a crash and injury hazard.

    Product
    SRAM Hydraulic Road Rim Brakes and Hydraulic Road Disc Brakes for bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V007000·2014-01-13

    General Motors Recalls 2014-2015 Trucks and SUVs for Engine Fire Risk

    General Motors is recalling specific 2014-2015 Chevrolet, GMC, and Cadillac vehicles because overheated exhaust components may melt plastic parts and cause an engine fire.

    Product
    GMC — GMC, CHEVROLET, CADILLAC SIERRA, SILVERADO, ESCALADE, YUKON
    Category
    Vehicle
    Distribution
    Distributed nationwide