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.

22501–22525 of 32171

  • SevereFDA (Drugs)·D-1236-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal Systems because they failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2060-2015·2015-07-22

    Zimmer Recalls ZNN Antegrade Femoral Nail Due to Potential Denting

    Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.

    Product
    ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-2852-2015·2015-07-22

    Dr. Praeger's Gluten Free Veggie Burgers Recalled for Undeclared Soy

    Ungar's Food Products is recalling Dr. Praeger's Gluten Free California Veggie Burgers because they contain undeclared soy.

    Product
    Dr. Praeger's California Veggie Burgers Gluten Free 11 oz. Manufactured by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA UPC 080868000602
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2063-2015·2015-07-22

    Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size

    Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-1240-2015·2015-07-22

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 314,600 bags of 0.9% Sodium Chloride Injection USP due to potential channel leaks that may compromise sterility.

    Product
    0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-2854-2015·2015-07-22

    Natural Grocers Caribbean Fruit & Nut Mix Recalled for Salmonella Risk

    Vitamin Cottage is recalling Natural Grocers Caribbean Fruit & Nut Mix because macadamia nuts in the product may be contaminated with Salmonella.

    Product
    Natural Grocers Caribbean Fruit & Nut Mix, Net Wt. (10 oz) (283g), packaged in plastic bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2085-2015·2015-07-22

    ViewRay Patient Handling System Software Recalled for Unexpected Movement

    ViewRay is recalling three units of Patient Handling System software due to a report of the couch moving unexpectedly into the bore after a reboot.

    Product
    Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2082-2015·2015-07-22

    FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect

    Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.

    Product
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2847-2015·2015-07-22

    Lion Pavilion Recalls Grassplot Ginger Slices for Undeclared Sulfites

    Lion Pavilion Ltd. is recalling Grassplot Ginger Slices because the product contains undeclared sulfites. Consumers with this product should stop using it.

    Product
    Grassplot Ginger Slice, NET WT. 3.5 OZ. (100g) , UPC 7246 6247, PRODUCT OF CHINA --- Firms on label: Manufactory: Grassplot Foodstuff Factory ADD: Huangshan Road, Huangshan Mansion, suite 417 Shantou, Guangdong, China -- Distributed by: LION PAVILION LIMITED --- Nutrition…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V457000·2015-07-22

    Kenworth Trucks Recalled for Reversed Air Brake Line Installation

    PACCAR is recalling 2016 Kenworth trucks because reversed air brake lines may prevent the redundant braking system from working correctly during a failure.

    Product
    KENWORTH — KENWORTH T660, T680, T880, T440
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V454000·2015-07-21

    Allied Recreation Recalls 2016 Motorhomes Due to Propane Regulator Defect

    Allied Recreation Group is recalling 92 model year 2016 motorhomes because an incorrect propane regulator may allow moisture buildup, potentially causing a gas leak and fire.

    Product
    FLEETWOOD — FLEETWOOD, MONACO, HOLIDAY RAMBLER TIOGA RANGER, TREK, TERRA SE, STORM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15188·2015-07-21

    Target Recalls Circo Night Lights Due to Fire Hazard

    Target is recalling about 143,000 Circo Night Lights because the battery can overheat and cause the light to melt, posing a fire hazard.

    Product
    Circo Night Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V451000·2015-07-20

    Mazda Recalls 2007-2014 CX-9 Vehicles for Front Suspension Defect

    Mazda is recalling 2007-2014 CX-9 vehicles because front suspension ball joints may corrode, potentially causing loss of steering control and increasing crash risk.

    Product
    MAZDA — MAZDA CX-9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E061000·2015-07-17

    SAF-Holland Recalls CBX Series Trailer Suspension Systems for Pivot Bolt Failure

    SAF-Holland is recalling CBX series trailer suspension systems because pivot bolts may fail, potentially causing the axle to separate from the trailer and increasing crash risk.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V450000·2015-07-17

    BMW Recalls 2014-2015 MINI Cooper Models for Side Impact Defect

    BMW is recalling 2014-2015 MINI Cooper, Cooper S, and John Cooper Works vehicles because rear seats fail federal side impact safety standards, increasing injury risk.

    Product
    MINI — MINI JOHN COOPER WORKS, COOPER S, COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1216-2015·2015-07-15

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira is recalling Bupivacaine Hydrochloride Injection vials because they contain free-floating and embedded iron oxide particles.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E060000·2015-07-15

    Flex-A-Lite Recalls Electric Fan Kits Due to Fire Risk

    Flex-A-Lite is recalling specific electric fan kits because missing fuse holders and insufficient circuit breakers may cause electrical damage and vehicle fires.

    Product
    ENGINE AND ENGINE COOLING:COOLING SYSTEM:FAN recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2816-2015·2015-07-15

    Garden Fresh Potato Salad Kit Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Steakhouse Potato Salad Kits after one case tested presumptive for Listeria monocytogenes. The product was distributed in Illinois.

    Product
    Garden Fresh Steakhouse Potato Salad Kit, CODE#1076, NET WT 10.75 LBS (4.876 KG) , UPC 0 01 11596 51076 4.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1989-2015·2015-07-15

    Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides

    Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.

    Product
    Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·101-2015·2015-07-15

    Aspen Foods Recalls Frozen Raw Stuffed Chicken Due to Salmonella Risk

    Aspen Foods is recalling approximately 1.98 million pounds of frozen, raw, stuffed, and breaded chicken products due to possible Salmonella Enteritidis contamination linked to illnesses in Minnesota.

    Product
    Aspen Foods Recalls Frozen, Raw, Stuffed & Breaded Chicken Products Due to Possible Salmonella Enteritidis Contamination
    Category
    Food
    Distribution
    1 state