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.

18676–18700 of 32108

  • SevereFDA (Food)·F-0554-2017·2016-12-07

    Island Soups Fish Soup Recalled for Possible Botulism Contamination

    Island Soups Company Inc. is recalling Fish Soup due to possible contamination with Clostridium botulinum. The product was distributed nationwide via internet orders.

    Product
    ISLAND SOUPS, FISH SOUP, NET WT. 16 OZ (28.4G)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0553-2017·2016-12-07

    Island Soups Red Peas Soup Recalled for Botulism Risk

    Island Soups Company Inc. is recalling Red Peas Soup due to possible contamination with Clostridium botulinum. Consumers should check their pantry for affected cans.

    Product
    ISLAND SOUPS, RED PEAS SOUP, NET WT. 16 OZ (28.4G)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0443-2017·2016-12-07

    Kuster's Recalls Pepper Jack Cheese Due to Listeria Risk

    Kuster's Inc. is voluntarily recalling 363 lbs of Pepper Jack cut cheese due to potential Listeria monocytogenes contamination or inadequate pasteurization.

    Product
    A New Dairy Pepper Jack cut Cheese, 5 lb. packages packed in plastic bags, keep refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0434-2017·2016-12-07

    Kuster's Dairy Foods Shredded Cheese Recalled for Listeria Risk

    Kuster's Inc. is voluntarily recalling specific 5 lb. packages of Three Blend Shredded Cheese due to potential Listeria monocytogenes contamination or inadequate pasteurization.

    Product
    Kuster's Dairy Foods Three Blend Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0551-2017·2016-12-07

    Island Soups Gungo Peas Soup Recalled for Botulism Risk

    Island Soups Company Inc. is recalling Gungo Peas Soup due to possible contamination with Clostridium botulinum. The product was distributed nationwide via internet orders.

    Product
    ISLAND SOUPS, GUNGO PEAS SOUP, NET WT. 16 OZ (28.4G)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0164-2017·2016-12-07

    Cadila Pharmaceuticals Recalls Microbially Contaminated Ondansetron HCI API

    Cadila Pharmaceuticals is recalling bulk Ondansetron HCI API due to microbial contamination. The affected product was distributed to two US consignees.

    Product
    Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0442-2017·2016-12-07

    Kuster's Dairy Foods Sliced Colby Jack Cheese Recalled for Listeria Risk

    Kuster's Inc. is voluntarily recalling sliced Colby Jack cheese due to potential Listeria monocytogenes contamination or inadequate pasteurization.

    Product
    Kuster's Dairy Foods Sliced Colby JackCheese, 5 lb. packages packed in plastic bags, keep refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0549-2017·2016-12-07

    Island Soups Mannish Water Recalled for Possible Botulism Contamination

    Island Soups Company Inc. is recalling Mannish Water soup due to possible contamination with Clostridium botulinum. Products were sold nationwide via internet orders.

    Product
    ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0440-2017·2016-12-07

    Kuster's Inc. Recalls Shredded Cheese Due to Listeria Risk

    Kuster's Inc. is voluntarily recalling shredded, sliced, and cubed cheese due to potential Listeria monocytogenes contamination or inadequate pasteurization.

    Product
    Nor-Tech Dairy Sharp White Cheddar Feather Shred Cheese, 5 lb. packages packed in plastic bags, keep refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0367-2017·2016-12-07

    Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure

    Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.

    Product
    Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468…
    Category
    Medical Device
    Distribution
    8 states
  • SevereNHTSA·16V879000·2016-12-07

    Heartland Landmark 365 Fifth Wheel Trailer Recall for Brake Line Wear

    Heartland is recalling 2016-2017 Landmark 365 fifth wheel trailers because the spare wheel may rub against the brake line, causing wear and potential loss of braking.

    Product
    HEARTLAND — HEARTLAND LANDMARK 365
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0552-2017·2016-12-07

    Island Soups Red Peas Soup Recalled for Botulism Risk

    Island Soups Company Inc. is recalling Red Peas Soup No Meat due to possible contamination with Clostridium botulinum.

    Product
    ISLAND SOUPS, RED PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0660-2017·2016-12-07

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.

    Product
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    26 states
  • SevereNHTSA·16E091000·2016-12-06

    Tesla Recalls Universal Mobile Connector Adapters Due to Fire Risk

    Tesla is recalling specific Universal Mobile Connector Adapters because insufficient welds may cause overheating or arcing, increasing the risk of a fire.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V877000·2016-12-06

    Indian Recalls 2014-2017 Motorcycles Due to Fuel Rail Leak Risk

    Indian Motorcycle is recalling 2014-2017 models because the fuel rail may contact other components, causing a fuel leak that increases fire risk.

    Product
    INDIAN — INDIAN CHIEF CLASSIC, ROADMASTER, SPRINGFIELD, CHIEF DARK HORSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V874000·2016-12-05

    Ford Recalls 2017 Fusion Vehicles for Rear Seat Back Weld Defect

    Ford is recalling 2017 Fusion vehicles because improperly welded left rear seat back pivot pins may fail in a crash, allowing luggage to move into the passenger compartment.

    Product
    FORD — FORD FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V870000·2016-12-02

    GM Recalls 2017 Chevrolet Malibu for Rear Side Air Bag Defect

    General Motors is recalling 2017 Chevrolet Malibus because the right-hand rear side air bag inflator manifold may have insufficient welds, posing a risk of debris or failure during a crash.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2017·2016-11-30

    Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips

    Hospira is recalling specific lots of Fentanyl Citrate Injection ampules because broken tips may compromise sterility.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0503-2017·2016-11-30

    JML Holdings Recalls Three Way Popcorn Sampler for Undeclared Eggs

    JML Holdings Inc is recalling Three Way Popcorn Sampler products due to undeclared eggs on the label. The products were distributed in Illinois, Michigan, and Ohio.

    Product
    Three Way Popcorn Sampler that contains three types of popcorn (cheese, carmel and buttered popcorn) packed inside one unlabeled clear plastic bag, physically divided by a three-way paperboard divider. The bag is packed inside a metal tin.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0653-2017·2016-11-30

    AtriCure Recalls COBRA Fusion Ablation Systems Due to Component Separation Risk

    AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.

    Product
    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when…
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-0527-2017·2016-11-30

    Free2b Sun Cups Chocolate Recalled for Potential Milk Contamination

    Seth Ellis Chocolatier is recalling Free2b Sun Cups Chocolate due to potential contamination with milk ingredients. The recall covers 189 master cases distributed nationwide.

    Product
    Free2b Sun Cups Chocolate. Made With SunButter Sunflower Spread. Packaged in 2 Cups. Net weight 1.5 oz (45g) and 1 Cup. Net weight 0.75 oz (21g)
    Category
    Food
    Distribution
    Distributed nationwide