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.

16201–16225 of 29206

  • SevereFDA (Food)·F-1886-2017·2017-04-19

    Lake Fresh Smoked Tilapia Recalled for Un-Removed Internal Organs

    Capital Street LLC is recalling Lake Fresh Whole Smoked Tilapia because New York State sampling found the fish was not eviscerated.

    Product
    Lake Fresh Whole Smoked Tilapia Net Wt 8 oz Capital Street LLC Old Bridge, NJ 08857 UPC 0680296079
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1925-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Black and Tan Bar for Undeclared Allergens

    Dolcetta Artisan Sweets is recalling 50 bars of Black and Tan Bar in Oregon and Washington due to undeclared soy lecithin and milk.

    Product
    Black and Tan Bar contains dark chocolate and white chocolate with cocoa nibs, 1.2 oz (33g), Product wrapped in metal foil and then wrapped in a paper box.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0658-2017·2017-04-19

    FDA Recalls Testosterone Micronized Bulk Due to cGMP Deviations

    Qinhuangdao Zizhu Pharmaceutical is recalling Testosterone Micronized Bulk due to cGMP deviations and lack of quality assurance. The product was distributed to six states.

    Product
    Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1761-2017·2017-04-19

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors

    PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.

    Product
    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Food)·F-1915-2017·2017-04-19

    J & J Distributing Recalls Cranberry Walnut Salad Due to Metal Contamination

    J & J Distributing Company is recalling specific Cub Foods and Kowalski's Markets Cranberry Walnut Salad products because shredded carrot ingredients were contaminated with metal pieces.

    Product
    Cub Foods (Fresh), Cranberry Walnut Salad, UPC 0-41144-37302-5, 20 0z. Plastic deli container. Kowalski's Markets, Salad Greens, Cranberry Walnut Salad, UPC 6-10014-14320-6, 9 oz. Plastic container.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V263000·2017-04-19

    Gillig Recalls 2015-2016 Low Floor Buses for Suspension Defect

    Gillig is recalling 2,604 Low Floor transit buses because improperly seated snap rings in the suspension kneeling modules may cause a loss of air pressure, increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1872-2017·2017-04-19

    Whole Foods Recalls Vulto Creamery Raw Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Vulto Creamery Walton Umber raw milk cheese due to possible contamination with Listeria monocytogenes.

    Product
    Vulto Creamery Walton Umber raw milk cheese cut and wrapped in clear plastic
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1773-2017·2017-04-19

    Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure

    Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.

    Product
    Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2017·2017-04-19

    Medisca Recalls Estrone USP Bulk Due to cGMP Deviations

    Medisca, Inc. is recalling Estrone, USP Bulk in various bottle sizes due to current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.

    Product
    ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1865-2017·2017-04-19

    Tomales Bay Foods Recalls Miranda Cheese Due to Listeria Risk

    Tomales Bay Foods is recalling specific lots of Miranda cheese because the supplier reported potential Listeria monocytogenes contamination.

    Product
    Miranda, 5 lb. wrapped in paper; Vulto Creamery, Walton, NY.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1702-2017·2017-04-19

    Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation

    Medtronic is recalling StrataMR valves and shunts because incorrect rotor orientation can cause underdrainage of cerebrospinal fluid, potentially leading to serious health consequences.

    Product
    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1947-2017·2017-04-19

    Dolcetta S'more Bars Recalled for Undeclared Soy and Milk Allergens

    Dolcetta Artisan Sweets is recalling 50 S'more Bars in Oregon and Washington due to undeclared soy lecithin and milk.

    Product
    S'more Bar contains dark chocolate and toasted white chocolate with graham cracker, 1.2 oz (33g), Product wrapped in metal foil and then wrapped in paper box. The label declared "***SMores Bar *** 60% dark chocolate, 32% white chocolate, graham crackers (wheat), vanilla bean…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0657-2017·2017-04-19

    FDA Recalls Estrone Micronized Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Food)·F-1901-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

    The SoyNut Butter Company is recalling I.M. Healthy Creamy SoyNut Butter nationwide due to potential E. coli O157 contamination.

    Product
    I.M. Healthy, Creamy SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E021000·2017-04-18

    Cummins Recalls ISV5.0 Diesel Engines in Tiffin Breeze Motorhomes

    Cummins is recalling ISV5.0 diesel engines in Tiffin Breeze motorhomes because a fan support bearing may fail, causing the engine to stall and increasing crash risk.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V255000·2017-04-18

    Micro Bird Recalls MB II School Buses for Roof Crush Risk

    Micro Bird is recalling 2012-2017 MB II school buses because the roof may crush during a rollover, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E020000·2017-04-13

    FiveCubits Recalls TREQ-VMx Tablets Due to Battery Overheating Risk

    FiveCubits is recalling TREQ-VMx mobile data tablets used by commercial truck operators because the lithium ion polymer batteries may overheat, increasing the risk of fire.

    Product
    ELECTRICAL SYSTEM:SOFTWARE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V253000·2017-04-13

    Nissan Recalls Sentra and Leaf Vehicles for Air Bag Defect

    Nissan is recalling 2014-2017 Sentra and 2015-2017 Leaf vehicles because the front passenger air bag may not deploy properly in a crash.

    Product
    NISSAN — NISSAN LEAF, SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2017·2017-04-12

    SCA Pharmaceuticals Recalls Vancomycin HCl IV Bags Due to Particulate Matter

    SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.5 gram IV bags due to the presence of particulate matter.

    Product
    Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V252000·2017-04-12

    Mercedes-Benz Recalls Vehicles for Steering Coupling Bolt Tightening Issue

    Mercedes-Benz is recalling specific 2013-2015 models because an insufficiently tightened steering bolt may cause loss of steering, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLK250, AMG C63, C250, GLK350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide