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.

351–375 of 758

  • CriticalFDA (Food)·F-0511-2024·2023-12-20

    Wilcox Premium Sea Salt Caramel Ice Cream Recalled for Listeria Contamination

    Wilcox Premium Sea Salt Caramel ice cream is being recalled for potential Listeria monocytogenes contamination. Affected products with best-by dates of 9/14/24 to 11/14/24 were distributed in VT, NH, MA, and NY.

    Product
    Wilcox Premium Sea Salt Caramel; 4 oz Cup; UPC 04372600404; Wilcox Premium Sea Salt Caramel in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0616-2024·2023-12-13

    Pico de gallo mix recalled for potential salmonella contamination

    Market Cuts LLC recalls 10-ounce pico de gallo with pineapple clamshells due to potential salmonella contamination. Products with best-by dates November 4–9, 2023, were distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    (No brand) 10 oz Mix Pico de Gallo w/Pineapple 3/8" 10 Ounce clamshell UPC 092538003233; Freshly Made Pico de Gallo w/Pineapple Mix 10 Ounce clamshell UPC 092538003233; Market Cuts 10 oz Mix Pico de Gallo w/Pineapple 3/8" 10 Ounce clamshell UPC 092538003233
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0501-2024·2023-12-13

    Turkey Gravy Recalled Due to Undeclared Soy Allergen

    Hy-Vee Turkey Gravy is recalled because it contains undeclared soy. The affected product was distributed to two Hy-Vee distribution centers in Iowa, with 2,000 jars recalled.

    Product
    HyVee Turkey Gravy, Net Wt 12 oz (340g). UPC 0 75450-03608 4. Distributed by Hy-Vee, Inc., West Des Moines, IA 50266
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0502-2024·2023-12-13

    Hilltop Meadow Farm Raw Milk Cheese Recalled for Listeria Risk

    Hilltop Meadow Farm is recalling Raw Milk Pepper Jack Cheese for potential Listeria monocytogenes contamination. Affected products have sell-by dates through September 2023 and were distributed to retailers in PA, NJ, NY, and WI.

    Product
    Hilltop Meadow Farm Raw Milk Cheese Pepper Jack Aged 60 Days .5 lb., 1 lb., 1.15 lb, 2.5 lb., and 5 lb. UPC: 0 200144 612644. Packaged in clear plastic packaging.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0671-2024·2023-12-13

    Bix Produce Recalls Fruit Medley for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling 91 units of Bix Produce Item #12170 (5 lb. Chunk Melon w/Grape) distributed in Iowa, Minnesota, North Dakota, and Wisconsin due to potential Salmonella contamination.

    Product
    Bix Produce Item # 12170 Fruit, Chunk Melon w/Grape 5 lb. containing Cantaloupe, Honeydew, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0472-2024·2023-12-06

    Le Croissant Chicken Salad recalled for undeclared milk and soy allergens

    Le Croissant Chicken Salad (5.8 oz, sold as Jack & Olive, Sprig & Sprout, or Food Unlimited) has been recalled due to undeclared milk and soy allergens. Approximately 4,146 units were distributed across 15 states and Washington D.C.

    Product
    Le Croissant Chicken Salad Net Wt. 5.8oz (164g) UPCs:766375795018, 766375797128, 766375261599, 766375261599 Packaged in clamshell container. Sold under 3 brands: Jack & Olive, Sprig & Sprout, and Food Unlimited. Sold as single unit and 6-unit pack
    Category
    Food
    Distribution
    0 states
  • CriticalCPSC·24719·2023-11-30

    Peg Perego Inclined Sleeper Bassinets Recalled for Suffocation and Fall Risk

    Peg Perego has recalled YPSI and Z4 inclined sleeper bassinets because they violate federal safety standards for infant sleep products and pose a risk of suffocation and falls.

    Product
    YPSI and Z4 Inclined Sleeper Bassinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0234-2024·2023-11-29

    VariSoft Insulin Infusion Set Recalled Over Premature Connector Disconnection

    Unomedical recalls 3,362 units of VariSoft infusion sets due to connector damage causing premature disconnection and missed insulin doses, risking dangerous elevation of blood glucose and ketone levels.

    Product
    VariSoft infusion set, Model Number 1002830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0131-2024·2023-11-29

    Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility

    Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0107-2024·2023-11-29

    Polyvinyl Alcohol Eye Drops Recalled for Non-Sterile Manufacturing Conditions

    FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.

    Product
    Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0132-2024·2023-11-29

    FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    0 states
  • 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
    0 states
  • CriticalFDA (Food)·F-0443-2024·2023-11-22

    Frozen Ice Cream Base Recalled for Undeclared Milk Allergen and Food Colorings

    Paradise Flavors LLC recalls Dulce de Leche ice-cream base (4 oz) for undeclared milk allergen and color additives. The recall affects 210 units distributed in Florida.

    Product
    DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 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-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
    0 states
  • 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-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-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-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-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-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
  • 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