The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

1451–1475 of 4878

  • SevereFDA (Food)·F-0641-2024·2023-12-27

    Aviator Dehydrated Tomato Halves Recalled for Undeclared Sulfites

    Aviator Dehydrated Tomato Halves are recalled due to undeclared sulfites. Sulfites are allergens that can trigger reactions in sensitive individuals.

    Product
    Aviator Dehydrated Tomato Halves, Net Wt. 4x2.27kg (5lbs)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0537-2024·2023-12-27

    AirFit F20 Full Face Mask recalled for magnetic interference with medical implants

    ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.

    Product
    AirFit F20 Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0549-2024·2023-12-27

    Infusion pump recalled for mechanical valve interference interrupting therapy delivery

    Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0153-2024·2023-12-27

    FDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure

    The FDA recalled Phenytoin Oral Suspension from Major Pharmaceuticals due to failed content uniformity specifications affecting 3,718 units distributed nationwide.

    Product
    Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2024·2023-12-27

    AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk

    ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.

    Product
    AirFit F30i Full Face Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0511-2024·2023-12-27

    IV Flush Syringes and Irrigation Solutions Recalled for Sterility Defect

    Nurse Assist, LLC recalls sodium chloride irrigation solutions and IV flush syringes due to potential lack of sterility assurance, which could allow contamination and infections.

    Product
    0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0687-2024·2023-12-27

    Tropical Fruit Bowl recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling Tropical Fruit Bowl 4/24 oz packages due to potential Salmonella contamination. Affected products with use dates 11/2/2023 to 11/24/2023 were distributed in eight states.

    Product
    TROPICAL FRUIT BOWL 4/24 OZ Packaged in clamshell containers. UPC: 840219193786
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0682-2024·2023-12-27

    Mixed Fruit Products Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling various mixed fruit products distributed across eastern states due to potential Salmonella contamination.

    Product
    Mixed Fruit: Mixed Fruit Burst 6/10 oz. UPC: 840219168357 Packaged in clamshell containers Mixed Fruit Chunk 4/32 oz. UPC: 840219109947 Packaged in clamshell containers Mixed Fruit Chunk 4/6 oz. UPC: 840219198606 Packaged in clamshell containers Mixed Fruit Chunks 1" 20 lb. UPC:
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0621-2024·2023-12-27

    Kwik Trip Mixed Fruit Tray Recalled for Potential Salmonella Contamination

    Kwik Trip Mixed Fruit Tray is recalled for potential Salmonella contamination. Approximately 77,013 units were distributed in six states with sell-by dates from Nov. 4 to Dec. 3, 2023.

    Product
    Kwik Trip Mixed Fruit Tray, Item 930941. Net Wt 16 oz (1 lb.) 454g. UPC 0 39779-00248 4. Produced & Distributed by Kwik Trip Inc., La Crosse WI
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0642-2024·2023-12-27

    Holiday Nogg Recall Due to Undeclared Egg Allergen

    United Dairy Farmers Holiday Nogg may contain undeclared egg allergen. Consumers with egg allergies should not consume the product and should contact the company for refund information.

    Product
    United Dairy Farmers - Holiday Nogg packaged in clear plastic HDPR 1/2 gallon jug. UPC: 076310050493
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0536-2024·2023-12-27

    ResMed AirFit N10 Nasal Masks Recalled for Magnetic Interference with Medical Implants

    ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.

    Product
    AirFit N10 Nasal Masks and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2024·2023-12-27

    AirFit N20 Nasal Mask: Magnetic Interference with Medical Implants

    ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.

    Product
    AirFit N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0540-2024·2023-12-27

    AirTouch N20 Nasal Mask recalled for magnetic interference with medical implants

    ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.

    Product
    AirTouch N20 Nasal Mask and User Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0649-2024·2023-12-27

    HMC Farms Nectarines recalled for potential Listeria contamination

    HMC Farms Signature Farms Nectarines in 2lb bags are recalled due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and to Mexico, Canada, and Taiwan.

    Product
    HMC Farms Nectarines Signature Farms 2lb bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0681-2024·2023-12-27

    Mixed Fruit Burst Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Burst 6/10 oz packages due to potential Salmonella contamination. The recall affects products distributed across eight states with use-by dates from November 2–24, 2023.

    Product
    MIXED FRUIT BURST 6/10 OZ Packaged in clamshell containers. UPC: 840219168357
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0678-2024·2023-12-27

    MIX FRUIT ALOHA BOWL recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling MIX FRUIT ALOHA BOWL due to potential Salmonella contamination. Affected products were distributed in PA, NJ, MD, WV, SC, VA, DE, NC, and NY.

    Product
    MIX FRUIT ALOHA BOWL 3/48 OZ Packaged in clamshell container. UPC:840219170299
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0674-2024·2023-12-27

    Cantaloupe chunks and spears recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling cantaloupe chunks and spears due to potential Salmonella contamination. The products were distributed in Pennsylvania, New Jersey, Maryland, West Virginia, South Carolina, Virginia, Delaware, North Carolina, and New York.

    Product
    Cantaloupe Chunks/Spears: Cantaloupe Chunks 1" 50/2 oz. Packaged in film UPC: 840219184845 Cantaloupe Chunks 1" 2/5 lb. Packaged in trays. UPC: 840219184449 Cantaloupe Chunks 6/16oz. Packaged in clamshell containers. UPC: 840219150345 Cantaloupe Chunks 50/2 oz. Packaged in fil
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0627-2024·2023-12-27

    Large Fruit Tray with Dip Recalled for Salmonella Contamination

    Renaissance Food Group is recalling Large Fruit Tray with Dip products distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina due to potential Salmonella contamination. Consumers who purchased affected products should not consume them.

    Product
    Large Fruit Tray with Dip NET WT 73.5 OZ (4 LBS (.5 OZ) 2.08 kg UPC 8 26766 19101 7 Dist. By: Renaissance Food Group LLC Rancho Cordova, CA 95670
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0685-2024·2023-12-27

    Mixed Fruit Melon Medley Chunk Recalled for Potential Salmonella Contamination

    TGD Cuts, LLC is recalling Mixed Fruit Melon Medley Chunk products due to potential Salmonella contamination. Affected products with use-by dates from November 2 to November 23, 2023 were distributed in eight states.

    Product
    MIXED FRUIT MELON MEDLEY CHUNK 4/32 OZ, 6/16 OZ. Packaged in clamshell containers. UPCs: 840219109954 and 840219109961
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0647-2024·2023-12-27

    HMC Farms White Nectarines recalled due to potential Listeria contamination

    HMC Farms White Nectarines 2lb Gusset Bags are recalled due to potential contamination with Listeria monocytogenes. The affected product was distributed across the United States and internationally.

    Product
    HMC Farms White Nectarines 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0608-2024·2023-12-27

    Dark Chocolate Coins Recalled for Undeclared Milk Allergen

    Manischewitz Magic Max's Dark Chocolate Coins are recalled due to undeclared milk from mispackaging. The product was distributed to retailers in multiple states and may affect consumers with milk allergies.

    Product
    Manischewitz Magic Max's Dark Chocolate Coins, NET WT. 0.53 OZ (15g), UPC: 072700200387 Display Box UPC: 072700200356, 12 bags per case. Product packaged in gold foil in blue netting bags.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-0512-2024·2023-12-27

    Sodium Chloride IV Flush Kits Recalled for Potential Sterility Failure

    Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.

    Product
    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0644-2024·2023-12-27

    HMC Farms Nectarines recalled due to Listeria monocytogenes contamination

    HMC Farms Nectarines in 2lb gusset bags are being recalled due to potential Listeria monocytogenes contamination. The product has been distributed across the United States and internationally.

    Product
    HMC Farms Nectarines 2lb Gusset Bag
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0679-2024·2023-12-27

    Mixed Fruit Luau Bowl recalled for potential Salmonella contamination

    TGD Cuts, LLC is recalling Mix Fruit Luau Bowl products due to potential Salmonella contamination. Affected units were distributed in eight states with use-by dates from November 2-23, 2023.

    Product
    MIX FRUIT LUAU BOWL 3/56 OZ Packaged in clamshell containers. UPC: 840219171753
    Category
    Food
    Distribution
    9 states
  • SevereCPSC·24064·2023-12-21

    Brandline HEAO 4-in-1 High Chairs Recalled for Suffocation and Laceration Risks

    Brandline is recalling about 820 HEAO 4-in-1 high chairs sold on Amazon from November 2022 through September 2023 because they pose suffocation, finger laceration, and entrapment hazards. One child has suffered a laceration requiring medical attention.

    Product
    HEAO 4-in-1 High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide