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.

13201–13225 of 29186

  • SevereNHTSA·18V831000·2018-11-26

    Maserati Recalls 2014-2015 Models for Fuel Line Fire Risk

    Maserati is recalling 2014-2015 Quattroporte and Ghibli vehicles because damaged fuel lines may leak, increasing the risk of a fire.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 1,550 bottles of Isosorbide Dinitrate Tablets 20 mg due to cross-contamination with other products.

    Product
    Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2019·2018-11-21

    Zero Xtreme Dietary Supplement Recalled for Undeclared Sibutramine

    Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0448-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0428-2019·2018-11-21

    Cacao Market Dark Chocolate Bar Recalled for Undeclared Milk

    Maribel's Sweets is recalling Cacao Market Orange Peels 60% Dark Chocolate Bars because they contain undeclared milk.

    Product
    Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, NET WT. 2.8 oz. UPC code: 877708004803.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0417-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-0452-2019·2018-11-21

    Working Cow Coffee Ice Cream Recalled for Listeria Contamination Risk

    Working Cow Homemade Inc. is recalling 3-gallon tubs of Coffee Ice Cream due to potential Listeria monocytogenes contamination. The product was distributed to US consignees only.

    Product
    Coffee Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0426-2019·2018-11-21

    MarieBelle Matcha and White Chocolate Bar Recalled for Undeclared Milk

    Maribel's Sweets, Inc. is recalling MarieBelle brand Japanese Matcha and White Chocolate Bars because they contain undeclared milk.

    Product
    MarieBelle brand Japanese Matcha Japanese Green Tea and White Chocolate Bar, NET Wt. 2.82 oz. UPC code: 877708005886
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0518-2019·2018-11-21

    Working Cow Ice Cream Recalled for Listeria Contamination Risk

    Working Cow Homemade Inc. is recalling No Sugar Added Wild Wild Berry Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    No Sugar Added Wild Wild Berry Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0564-2019·2018-11-21

    Working Cow Homemade Inc. Recalls Chocolate Peanut Butter Ice Cream

    Working Cow Homemade Inc. is recalling 107 tubs of JY Chocolate Peanut Butter Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    JY Chocolate Peanut Butter Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0413-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits

    GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.

    Product
    Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0517-2019·2018-11-21

    Working Cow Homemade Inc. Recalls Malibu Coconut Rum Ice Cream

    Working Cow Homemade Inc. is recalling 514 tubs of Malibu Coconut Rum Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    Malibu Coconut Rum Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0494-2019·2018-11-21

    Working Cow Homemade Ice Cream Recalled for Listeria Risk

    Working Cow Homemade Inc. is recalling 786 tubs of No Sugar Added Salted Caramel with Pecans Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    No Sugar Added Salted Caramel with Pecans Ice Cream, 3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0525-2019·2018-11-21

    Working Cow Coffee Ice Cream Recalled for Listeria Risk

    Working Cow Homemade Inc. is recalling 470 tubs of No Sugar Added Coffee Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    No Sugar Added Coffee Ice Cream,3 gallons
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0521-2019·2018-11-21

    Working Cow Pistachio Ice Cream Recalled for Listeria Contamination

    Working Cow Homemade Inc. is recalling 501 tubs of No Sugar Added Pistachio Ice Cream due to potential Listeria monocytogenes contamination.

    Product
    No Sugar Added Pistachio Ice Cream ,3 gallons
    Category
    Food
    Distribution
    0 states