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.

25951–25975 of 32215

  • SevereFDA (Food)·F-1597-2014·2014-03-12

    Rise n Roll Bakery Recalls Caramel Donuts for Undeclared Egg

    Rise'n Roll Bakery is recalling Caramel Donuts because they contain egg, which is not listed on the label. Consumers with egg allergies should not eat the product.

    Product
    Rise n Roll Bakery & Deli, Caramel Donuts, sold individually and found in 6 count (436 g)UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Caramel Donuts Enriched wheat flour, soybean oil…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1613-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti cranberry dipped in white chocolate due to undeclared wheat, soy, and milk.

    Product
    Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1103-2014·2014-03-12

    Cyanocobalamin Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Cyanocobalamin 100mcg/ml injection due to quality control issues affecting sterility assurance.

    Product
    Cyanocobalamin 100mcg/ml injection
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1119-2014·2014-03-12

    Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns

    Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.

    Product
    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384…
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-1609-2014·2014-03-12

    Diamond Foods Recalls Bakes Sea Salt Potato Chips Due to Undeclared Milk

    Diamond Foods Inc is recalling Bakes Sea Salt Potato Chips because they may contain undeclared milk, which poses a risk to individuals with milk allergies.

    Product
    Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 10984 2. Case UPC 84114 10982 5.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-1125-2014·2014-03-12

    Novarel Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Novarel (IM) due to quality control issues affecting sterility assurance.

    Product
    Novarel (IM)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1594-2014·2014-03-12

    Rise n Roll Chocolate Donuts Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling chocolate donuts because they contain undeclared egg, a major food allergen.

    Product
    Rise n Roll Bakery & Deli, Chocolate Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Chocolate Donuts Enriched wheat flour, soybean oil…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1137-2014·2014-03-12

    Testosterone Cypionate Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all unexpired lots of Testosterone Cypionate 100mg/ml due to quality control issues affecting sterility.

    Product
    Testosterone Cypionate 100mg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·14V102000·2014-03-10

    Starcraft Prodigy and Quest School Buses Recalled for Door Actuator Fire Risk

    Starcraft Bus is recalling 281 model year 2009 and 2010 Prodigy and Quest school buses because voltage spikes may damage door actuator circuit boards, increasing the risk of a fire.

    Product
    STARCRAFT — STARCRAFT PRODIGY, QUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V108000·2014-03-07

    Eldorado Transit Bus Recall for Exhaust Fire Risk

    Eldorado is recalling certain transit buses because condensation in the engine intake may freeze, causing exhaust flames that risk fire or burn injuries.

    Product
    ENC — ENC XHF, EZ-RIDER II, AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V111000·2014-03-07

    CM Trailers Recalls 2012 Cargo Van and Revolution Trailers for Brake Defect

    CM Trailers is recalling 2012 Cargo Van and Revolution trailers because a manufacturing defect in the hydraulic brake pump could cause a loss of braking ability.

    Product
    CM TRAILERS — CM TRAILERS CARGO VAN, REVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·018-2014·2014-03-07

    George's Recalls Chicken Breast Strips Due to Undeclared Soy Allergen

    George's Inc. is recalling 29,200 pounds of seasoned raw chicken breast strips because the labels failed to declare soy protein and MSG.

    Product
    George's Further Processing — Arkansas Firm Recalls Chicken Products Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14E007000·2014-03-07

    Gates Recalls Tru-Flow Water Pumps for Timing Belt Failure Risk

    Gates is recalling specific aftermarket Tru-Flow water pumps for Audi and Volkswagen vehicles because the pulley may develop microfractures, causing the timing belt to fail and the engine to shut down.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI BEETLE, A4, TT, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14125·2014-03-06

    Packaging Tape Recalls Air Movers Due to Fire Hazard

    Packaging Tape is recalling about 2,800 air movers sold from 2008 to 2010 because a thermal switch failure can cause the motor to overheat and start a fire.

    Product
    Air movers/blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0952-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0954-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1549-2014·2014-03-05

    UNFI Recalls Kinnikinnick Waffles for Undeclared Milk Allergen

    UNFI is recalling Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles nationwide due to undeclared milk. The recall is voluntary and classified as Class I.

    Product
    Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300199 8
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1071-2014·2014-03-05

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.

    Product
    HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide