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.

1301–1325 of 4878

  • SevereFDA (Devices)·Z-0933-2024·2024-02-07

    EZDilate esophageal balloons recalled for inflation failure and device leaking

    Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.

    Product
    EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0928-2024·2024-02-07

    Monterey Jack Cheese Recalled for Listeria Monocytogenes Contamination

    Bulk Monterey Jack cheese from Rizo Lopez Foods is being recalled due to Listeria monocytogenes contamination. The product was distributed to multiple U.S. states.

    Product
    Monterey Jack Conventional (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0918-2024·2024-02-07

    Sour Cream Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods has recalled multiple sour cream and cream products due to Listeria monocytogenes contamination. Products were distributed across multiple U.S. states.

    Product
    Tio Francisco Crema Centroamericana 16 oz. UPC 7-27242-00440-4 Tio Francisco, Campesino Crema Centroamericana Available to consumers at retail deli counters in various sizes Tio Francisco Crema Latina 16 oz. UPC 7-27242-35445-5 Tio Francisco Crema Latina Available to consumer
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0774-2024·2024-02-07

    EVair Air Compressors Recalled for Elevated Formaldehyde Emissions

    EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.

    Product
    EVair air compressor, model numbers: M1230849 and M1230847
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0281-2024·2024-02-07

    Vancomycin IV bags recalled due to filling system malfunction causing double doses

    Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.

    Product
    VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0817-2024·2024-02-07

    Melissa's Hot Kimchi Pickled Napa Cabbage Recalled for Undeclared Fish Allergen

    Melissa's Hot Kimchi Pickled Napa Cabbage is being recalled due to undeclared fish allergen. 124 cases were distributed to California, Texas, and Florida.

    Product
    Melissa's Hot Kimchi Pickled Napa Cabbage NET WT. 14 oz (397g) Ingredients: Napa Cabbage, Radish, Water, Garlic, Red Pepper, Organic Sugar Cane, Sea Salt, Calcium Lactate, Ginger, Onion, Sorbitol, and Xanthan Gum. Produce on equipment that also processes products containing fi
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0923-2024·2024-02-07

    Tio Francisco Queso Seco Cheese Recalled for Listeria Monocytogenes

    Rizo Lopez Foods is recalling Tio Francisco Queso Seco 14 oz. cheese due to Listeria monocytogenes contamination. The product was distributed across multiple U.S. states with production dates through July 31, 2024.

    Product
    Tio Francisco Queso Seco 14 oz. UPC 7-27242-00548-8
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0925-2024·2024-02-07

    Ricotta cheese products recalled for Listeria monocytogenes contamination

    Multiple ricotta cheese products from Rizo Lopez Foods are recalled nationwide due to potential Listeria monocytogenes contamination. Affected batches have best-by dates through April 2, 2024.

    Product
    365 Whole Foods Market Ricotta Part Skim 15 oz. UPC 9-94824-63052 365 Whole Foods Market Ricotta Whole Milk 15 oz. UPC 9-94824-96245 Ricotta Part Skim 65%, 70%, 75% Moisture (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0775-2024·2024-02-07

    FDA recalls EVair 03 compressor models for elevated formaldehyde levels

    FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).

    Product
    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0804-2024·2024-02-07

    Salmon fillets recalled for potential Listeria monocytogenes contamination

    Ocean Group Inc. is recalling frozen salmon fillet products distributed in California due to potential Listeria monocytogenes contamination detected during FDA environmental sampling.

    Product
    202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB 202032 SALMON BAKKAFROST FAROE ISLANDS 8/9KG FR FRO F
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0917-2024·2024-02-07

    Cheese product recalled for Listeria monocytogenes contamination

    Rizo Lopez Foods is recalling Tio Francisco Blanco Suave cheese due to potential Listeria monocytogenes contamination. Affected products have date codes through March 23, 2024.

    Product
    Tio Francisco Blanco Suave 14 oz. UPC 7-27242-05355-6
    Category
    Food
    Distribution
    20 states
  • SevereNHTSA·24V245000·2024-02-04

    2021 Jayco Redhawk motorhomes recalled for power steering connection defect

    Certain 2021 Jayco Redhawk motorhomes have a defective power steering connection that can cause sudden loss of power steering and brake assist, increasing crash risk. Dealers will replace the defective parts free of charge.

    Product
    JAYCO — 2021 JAYCO REDHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V079000·2024-02-02

    2022-2023 BMW IX and X1 driver airbag may fail to deploy in crash

    Certain 2022 and 2023 BMW IX and X1 vehicles have defective driver-side airbags that may not deploy during a crash. Dealers will replace the airbags at no charge.

    Product
    BMW — 2023 BMW IX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24107·2024-02-01

    BISSELL Multi Reach Hand and Floor Vacuum Cleaners Recalled for Fire Hazard

    BISSELL is recalling about 142,000 Multi Reach Hand and Floor Vacuum Cleaners because the battery pack can overheat and smoke, creating a fire risk. Six reports included the battery catching fire, causing minor property damage and burn injuries in some cases.

    Product
    BISSELL® brand Multi Reach Hand and Floor Vacuum Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2024·2024-01-31

    Robitussin Honey CF Max Non-Drowsy Adult recalled for microbial contamination

    GSK Consumer Healthcare recalls Robitussin Honey CF Max Non-Drowsy Adult due to microbial contamination in non-sterile products distributed nationwide. Affected lot numbers carry specific expiration dates.

    Product
    Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0788-2024·2024-01-31

    Lara's Bakery 3 LLC Recalls Pan de Racho Bread for Undeclared Allergens

    Lara's Bakery 3 LLC recalls Pan de Racho (Feria) bread distributed in Iowa and Wisconsin for undeclared allergens including sesame, with potential presence of coconut, soy, wheat, milk, and eggs.

    Product
    Pan de Racho (Feria), Net Wt. 2lbs, individually packaged in clear plastic bag.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0317-2024·2024-01-31

    Robitussin Honey CF Max Nighttime Adult Recalled for Microbial Contamination

    Haleon US Holdings LLC is recalling Robitussin Honey CF Max Nighttime Adult cough medicine due to microbial contamination. The FDA Class I recall affects 21,900 bottles distributed nationwide.

    Product
    Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0784-2024·2024-01-31

    Publix Custom Made Platters Recalled Due to Potential Listeria Contamination

    Publix is recalling custom made platters distributed across eight states due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. Consumers should not eat platters prepared between December 5-14, 2023.

    Product
    Publix Custom Made Platters, variable weights and sizes, packed in plastic containers, intended for immediate consumption (https://www.publix.com/mc/order-ahead/order-deli-platters?nav=header).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0261-2024·2024-01-31

    Drug recall: Bleomycin injection vials recalled due to glass contamination

    Pfizer is recalling 3,546 vials of Bleomycin for Injection due to the presence of glass particulate matter. The affected lot was distributed nationwide in the USA, Netherlands, and Libya.

    Product
    BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0783-2024·2024-01-31

    Publix Deli Chicken Street Tacos Recalled for Listeria Contamination

    Publix Deli Chicken Street Tacos for Two sold in eight southeastern states are recalled due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. Consumers should not eat this product and should discard or return it.

    Product
    Publix Deli Chicken Street Tacos for Two, variable weights and sizes, packed in plastic containers, intended for immediate consumption (https://www.publix.com/pd/publix-deli-chicken-street-tacos-for-two/RIO-PCI-238408?origin=search1).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0777-2024·2024-01-31

    Outrageous Oat Cookies Recalled for Undeclared Wheat Allergen

    Wegmans Food Markets is recalling Outrageous Oat Cookies due to undeclared wheat. The product poses a serious health risk to consumers with wheat allergies or celiac disease.

    Product
    Outrageous Oat Cookies packaged in 5pk and also sold in Bulk
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0789-2024·2024-01-31

    Pan Surtido Bakery Products Recalled for Undeclared Allergens

    Lara's Bakery 3 LLC is recalling Pan Surtido multi-pack bakery trays distributed in Iowa and Wisconsin through November 2023 due to undeclared allergens including sesame, coconut, soy, and milk, with potential for wheat and eggs.

    Product
    Pan Surtido with label reading: Panaderia Lara's Bakery, 701 N 3rd Ave Suite C Marshalltown IA 50158. Multi-pack tray containing Concha, Cema, Polvoron, Tostado de Guatemala, Pan de Guatemala, Canasta, Garibaldi, Marianas, Muffin, Pan Fino, Pastel Glass, Pan de Trigo, Puerco, Bol
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0780-2024·2024-01-31

    Publix Sub Sandwiches Recalled for Potential Listeria Contamination

    Publix Custom Made Sub Sandwiches are being recalled due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient supplied by Fresh Express. Products were distributed between December 5-14, 2023 in southeastern states.

    Product
    Publix Custom Made Sub Sandwiches, variable weights and sizes, individually wrapped in paper, intended for immediate consumption (https://www.publix.com/menu-subs-and-wraps?merch=hp_viz_nav_subs_wraps).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0785-2024·2024-01-31

    Publix Self-Service Salad Recalled for Potential Listeria Contamination

    Publix is recalling self-service salad from its salad bar distributed December 5-14, 2023, in eight states due to potential Listeria monocytogenes contamination in shredded lettuce supplied by Fresh Express.

    Product
    Publix Self Service Salad from the Salad Bar, variable weights and sizes, packed in plastic containers, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states