The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. The hazard can cause serious injury or death. 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.

876–900 of 7451

  • CriticalFDA (Food)·F-0429-2024·2023-11-22

    Paradise Flavors frozen cappuccino ice-cream recalled for undeclared milk

    Paradise Flavors LLC is recalling 60 units of its frozen cappuccino ice-cream (4 oz pouches) from Florida due to undeclared milk allergen, which poses a serious risk to consumers with milk allergies.

    Product
    CAPPUCCINO, Ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0440-2024·2023-11-22

    Paradise Flavors frozen mamey recalled for undeclared milk allergen

    Paradise Flavors LLC is recalling 80 units of frozen MAMEY product due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    MAMEY, PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0339-2024·2023-11-15

    Diced yellow onions recalled for potential Salmonella Thompson contamination

    Gills Onions is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across the United States and Canada.

    Product
    Cross Valley Farms 1/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
    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-0324-2024·2023-11-15

    Little Bear Fresh Kale Recalled for Possible Listeria Contamination

    Little Bear Fresh Kale from Safeway Fresh Foods LLC is being recalled due to possible Listeria monocytogenes contamination. The recall affects 191 cases distributed in Texas.

    Product
    Little Bear Fresh Kale, Net Wt. 16oz
    Category
    Food
    Distribution
    1 state
  • 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-0389-2024·2023-11-15

    Diced yellow onions recalled due to Salmonella contamination risk

    Gills Onions is recalling PEAK brand diced yellow onions due to potential Salmonella contamination. Product was distributed across the United States and Canada.

    Product
    PEAK 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0371-2024·2023-11-15

    Sliced Red Onions Recalled Due to Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh sliced red onions due to potential Salmonella Thompson contamination. The product was distributed across 31 U.S. states and Canadian provinces.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 3/16" SLVERED RED ONIONS SYSCO
    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-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 (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
  • 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
  • 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-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-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