The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

851–875 of 7439

  • CriticalFDA (Food)·F-0399-2024·2023-11-15

    Slivered Yellow Onions Recalled for Salmonella Contamination Risk

    Gills Onions is recalling Ready Set Serve slivered yellow onions because of potential Salmonella Thompson contamination. The FDA has classified this as a Class I recall.

    Product
    Ready Set Serve 2/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0354-2024·2023-11-15

    Fresh Diced Yellow Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling 4,160 pounds of fresh diced yellow onions due to potential contamination with Salmonella Thompson. The products were distributed across the United States and Canada.

    Product
    Gills Onions 4/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0390-2024·2023-11-15

    Diced yellow onions recalled for potential Salmonella Thompson contamination

    Gills Onions, LLC is recalling specific lots of PEAK 4/5 lb fresh diced yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed across Canada and multiple U.S. states.

    Product
    PEAK 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0363-2024·2023-11-15

    Diced Yellow Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling fresh diced yellow onions due to potential Salmonella Thompson contamination. Approximately 16,400 pounds of product was distributed across multiple U.S. states and Canadian provinces.

    Product
    4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIPPER DARDEN
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0304-2024·2023-11-08

    FreshPoint Bix Produce Cantaloupe Recalled for Possible Salmonella Contamination

    FreshPoint Bix Produce cantaloupes are being recalled due to potential Salmonella contamination. The recalled product was distributed to Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    FreshPoint Bix Produce Company, Cantaloupe. Item # 03143. 3 melons per bag.
    Category
    Food
    Distribution
    4 states
  • CriticalUSDA FSIS·056-2023·2023-11-02

    Fairmont Foods Recalls Frozen Spaghetti Loops for Undeclared Egg Allergen

    Fairmont Foods is recalling approximately 147,132 pounds of frozen spaghetti loops with meat sauce due to misbranding and an undeclared egg allergen.

    Product
    Fairmont Foods, Inc. — Fairmont Foods, Inc., Recalls Frozen Spaghetti Loops With Meat Sauce Entree Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0149-2024·2023-11-01

    Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues

    Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.

    Product
    Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0288-2024·2023-10-25

    Mooncakes Recalled Due to Undeclared Egg Allergen

    Sheng Kee Bakery mooncakes recalled for undeclared egg allergen across CA, IL, TX, GA, WA, and NJ. Consumers with egg allergies should not consume.

    Product
    Small 12 -3 Flavor Assorted Mooncake Gift Box Small 12- 4 Flavor Assorted Mooncake Gift Box Small 12- 6 Flavor Assorted Mooncake Tin Gift Box Small 6- 3 Flavor Assorted Mooncake Gift Box Small 9- 3 Flavor Assorted Mooncake Gift Box Assorted Large 4 Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • CriticalCPSC·24011·2023-10-19

    Fortress Safe Biometric Gun Safes: Unauthorized Access and Risk of Death

    Xpedition LLC is recalling approximately 61,000 biometric gun safes because the biometric locks can be opened by unauthorized users, posing serious injury and death risks. One death has been reported in a recent lawsuit.

    Product
    Biometric Gun Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0028-2024·2023-10-18

    FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

    Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

    Product
    2008T Hemodialysis SYS, with CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0011-2024·2023-10-18

    Ginger Snap Milk Chocolate recalled for undeclared peanut allergen

    Dick Taylor Inc is recalling Ginger Snap Milk Chocolate due to undeclared peanut allergen. People with peanut allergies may experience serious allergic reaction if they consume this product.

    Product
    Ginger Snap Milk Chocolate, 2 oz wrapped
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0287-2024·2023-10-18

    Quaker Pancakes with Whole Grain Oats Recalled for Undeclared Soy Allergen

    Comercializadora Pepsico Mexico recalls Quaker Pancakes with Whole Grain Oats due to undeclared soy allergen. The product contains soy not listed on the label, creating a health risk for consumers with soy allergies.

    Product
    QUAKER PANCAKES WITH WHOLE GRAIN OATS, NET WT 15.97OZ (1LB)
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·049-2023·2023-10-16

    Phu Huong Recalls Beef and Poultry Meatballs Due to Listeria

    Phu Huong Food Company is recalling approximately 602 pounds of ready-to-eat beef and chicken meatballs due to possible Listeria monocytogenes contamination.

    Product
    Phu Huong Food Company, Inc. — Phu Huong Food Company Recalls Ready-To-Eat Beef and Poultry Meatball Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·047-2023·2023-10-13

    Don Miguel Recalls Frozen Carne Asada Burritos Due to Listeria Risk

    Don Miguel Foods is recalling approximately 10,642 pounds of frozen ready-to-eat carne asada burritos due to possible Listeria monocytogenes contamination.

    Product
    Don Miguel Mexican Foods, Inc. — Don Miguel Foods Recalls Frozen Ready-To-Eat Carne Asada Burrito Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0037-2024·2023-10-11

    FDA Recalls Dr. Berne's MSM Drops Due to Non-Sterility Concerns

    Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.

    Product
    Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·24002·2023-10-05

    Cocco Candy Rolling Candy Recalled Due to Choking Hazard

    KGR Distribution Corp. recalls Cocco Candy Rolling Candy in multiple flavors because the candy's rolling ball can dislodge and pose a choking hazard. One death has been reported.

    Product
    Cocco Candy Rolling Candy
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1689-2023·2023-10-04

    Dessert on Wheels Recalled Due to Listeria Contamination

    Ice Cream House is recalling Dessert on Wheels products sold in Ohio, New Jersey, and New York because they may be contaminated with Listeria monocytogenes. Consumers should not consume the affected products.

    Product
    Dessert on Wheels; dairy / parve; 4 PACK / SINGLE; UPC: 0-91404-15339-3
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1677-2023·2023-10-04

    Cup Cake Party products recalled due to Listeria monocytogenes contamination

    Ice Cream House is recalling Cup Cake Party products due to potential Listeria monocytogenes contamination. Products were distributed in Ohio, New Jersey, and New York.

    Product
    Cup Cake Party; dairy / parve; 6 PACK / SINGLE; UPC: 0-91404-15287-7
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1655-2023·2023-10-04

    Sorbet Swirl Ice Cream Recalled Due to Listeria Contamination Risk

    ICE CREAM HOUSE is recalling Sorbet Swirl ice cream due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, New Jersey, and New York.

    Product
    Sorbet Swirl; parve; 6 PACK / SINGLE; UPC: 0-91404-15400-0
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1644-2023·2023-10-04

    Ice Cream House Strawberry Shortcake Roll Recalled for Listeria Contamination

    Ice Cream House Strawberry Shortcake Roll products may contain Listeria monocytogenes. Consumers in Ohio, New Jersey, and New York should not consume affected products.

    Product
    {P} Strawberry Shortcake Roll; parve; 1 PACK / SINGLE; UPC: 0-91404-15298-0
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1631-2023·2023-10-04

    Heart Cakes from Ice Cream House Recalled for Listeria Contamination

    Heart cakes from Ice Cream House are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, New Jersey, and New York.

    Product
    10' Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15171-9 and 8' Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15309-6 and 6' Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15172-6 and Mini Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15173-3
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1635-2023·2023-10-04

    Round cake recalled for potential Listeria monocytogenes contamination

    Ice Cream House is recalling round cakes (UPC 0-91404-15181-8) distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    {P} 6' Round Cake; dairy / parve; 1 PACK; UPC: 0-91404-15181-8
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1601-2023·2023-10-04

    Hamburger Buns Recalled for Undeclared Milk Allergen in Michigan

    Knickerbocker Homestyle hamburger buns are recalled due to undeclared milk, posing risk to consumers with dairy allergies. The voluntary recall affects 668 retail units distributed to stores and restaurants in southeastern Michigan.

    Product
    Knickerbocker Homestyle hamburger buns, 16oz, 8 count in clear plastic bag, UPC 6 11625 10020 6
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1626-2023·2023-10-04

    FDA Recalls Ice Cream Pie for Listeria Monocytogenes Contamination

    ICE CREAM HOUSE is recalling 9-inch ice cream pies distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    9'' Ice Cream Pie Vanilla / Chocolate; dairy / parve; 1 PACK; UPC: 0-91404-15428-4
    Category
    Food
    Distribution
    3 states