The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

14001–14025 of 27206

  • ModerateFDA (Devices)·Z-0370-2024·2023-11-29

    Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.

    Product
    Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2024·2023-11-29

    Compress Device Short Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

    Product
    Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2024·2023-11-29

    Compress Device Short Anchor Plug recalled for potential metal burrs

    Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.

    Product
    Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0463-2024·2023-11-29

    Dietary Supplement Recalled for Subpotent Folic Acid Content

    ActiPharma is recalling ACTIRON Dietary Supplement (Lot 13309, Exp. 01/26) distributed in Puerto Rico because FDA testing found the folic acid content did not meet the label claim.

    Product
    ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0462-2024·2023-11-29

    Frozen Gluten-Free Waffles Recalled for Potential Peanut Contamination

    Treehouse Foods is recalling multiple brands of frozen gluten-free blueberry waffles due to potential peanut contamination. Affected products were distributed in California, Iowa, Illinois, Ohio, and Texas.

    Product
    HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant Eagle Blueberry Gluten Free Waffle, 11.3oz, UPC 030034944940 Topco Full Circle Market Gluten Free Waffles - Blueberry, 11.3oz, UPC 036800486980
    Category
    Food
    Distribution
    5 states
  • 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-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-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
  • SevereFDA (Food)·F-0447-2024·2023-11-22

    Pine Nut Ice Cream Bar Recalled for Undeclared Milk, Soy, Wheat, Tree Nuts

    Paradise Flavors LLC has recalled its 4 oz Pine Nut Ice Cream Bar due to undeclared allergens: milk, tree nuts, soy, and wheat. The product was distributed in Florida and poses a risk to consumers with these allergies.

    Product
    Pine Nut/Pinon, Ice Cream Bar, Ice cream base, natural flavoring, dehydrated fruit, artificial coloring, 4 oz, Paradise Flavors. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0428-2024·2023-11-22

    Pink Guaba Ice Cream Mix Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors LLC recalls Pink Guaba ice cream mix due to undeclared milk allergen and color additives. Consumers with milk allergies should not consume this product.

    Product
    PINK GUABA, Ice-cream mix, filtered water, Natural Flavoring, sugar, Artificial color. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0449-2024·2023-11-22

    Cookies And Cream Frozen Product Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Paradise Flavors LLC is recalling 318 units of Cookies And Cream frozen product (4 oz) due to undeclared allergens: milk, soy, and wheat. The product was distributed in Florida.

    Product
    Cookies And Cream, distributed by Paradise Flavors LLC, 4 OZ, 120ML, Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0433-2024·2023-11-22

    Ice Cream Base Recalled for Undeclared Milk Allergen and Food Dyes

    Paradise Flavors LLC is recalling RUM RAISIN ice-cream base (4 oz frozen pouches) distributed in Florida due to undeclared milk allergen and undeclared food dyes (FD&C yellow #5, red #40, blue #1). Consumers with milk allergies should not consume this product.

    Product
    RUM RAISIN, ice-cream base, artificial flavoring natural fruits, artificial. DISTRIBUTED PARADISE FLAVORS LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0437-2024·2023-11-22

    Paradise Flavors Key Lime Creamsicle frozen treats recalled for undeclared allergens

    Paradise Flavors is recalling Key Lime Creamsicle frozen desserts due to undeclared milk allergen and undeclared food color additives. Consumers with milk allergies should not consume this product.

    Product
    KEY LIME CREAMSICLE, Filtered water, ice-cream base, natural flavoring, artificial color, citric acid and carboxymethylcellulose. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0455-2024·2023-11-22

    Coconut ice cream mix recalled for undeclared milk and tree nut allergens

    Paradise Flavors LLC is recalling 216 units of COCONUT/COCO ice cream mix from Florida distribution due to undeclared milk and tree nut allergens. Consumers allergic to milk or tree nuts should not consume this product.

    Product
    COCONUT/COCO ice cream mix, natural flavors, artificial flavors. 9601 Overseas Hwy, Marathon FL. 100ml 3 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0439-2024·2023-11-22

    Paradise Flavors Rice Pudding Ice Cream Mix Recalled for Undeclared Milk

    Paradise Flavors Arroz con Leche rice pudding ice cream mix is recalled due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    ARROZ CON LECHE/RICE PUDDING, Ice cream MIX, Filtered water, Natural Rice, cinamon and caramel, DISTRIBUTOR PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0453-2024·2023-11-22

    Paradise Flavors Frozen Chocolate Ice Cream Recalled for Undeclared Milk and Soy

    Paradise Flavors LLC is recalling frozen chocolate ice cream (4 OZ/120 ML packages) distributed in Florida due to undeclared milk and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    CHOCOLATE, ice-cream base, chocolate powder, natural flavoring,. PARADISE FLAVORS, 4 OZ, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0454-2024·2023-11-22

    Frozen Avocado Ice-Cream Base Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC recalls its frozen avocado ice-cream base for undeclared milk allergen and FD&C color additives. The product was distributed in Florida and may pose a risk to milk-allergic consumers.

    Product
    Avocado, ice-cream base, Natural flavor, artificial coloring. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 OZ. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0461-2024·2023-11-22

    Frozen Cotton Candy with M&Ms recalled for undeclared allergens

    Paradise Flavors LLC is recalling Cotton Candy with M&Ms due to undeclared milk, peanuts, and soy allergens, plus undeclared color additives. The product was distributed in Florida.

    Product
    Cotton Candy with M&Ms, ice-cream base, M&M's, artificial flavor, food coloring. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 OZ. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0434-2024·2023-11-22

    Trail Mix Ice Cream Base Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling Trail Mix/Frutas Secas ice cream base because it contains undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with allergies to these ingredients should not consume the product.

    Product
    Trail Mix/Frutas Secas, Ice-cream base, dried fruits and nuts, vanilla extract. 9301 Overseas Hwy. Marathon FL 33050. CONTAINS NUTS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0452-2024·2023-11-22

    EZQUIMAL Ice Cream Base Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC recalls EZQUIMAL 4 oz frozen ice-cream base due to undeclared allergens (milk, tree nuts, peanuts, soy) and color additives. Product distributed in Florida.

    Product
    EZQUIMAL, ice-cream base, natural flavoring, chocolate cover, penuts. 4 OZ. DISTRIBUTED BY PARADISE FLAVORS LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0460-2024·2023-11-22

    Frozen Gummybear Ice Cream Recalled for Undeclared Milk, Tree Nuts, and Food Dye

    Paradise Flavors LLC is recalling BUBBLEGUM GUMMYBEAR frozen ice cream (4 oz pouches) due to undeclared allergens—milk and tree nuts—and an undeclared color additive (FD&C Blue #1). The product was distributed within Florida only.

    Product
    BUBBLEGUM GUMMYBEAR, ice-cream base, artificial flavor. Distributed by: PARADISE FLAVORS LLC. 4 OZ, 120ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0445-2024·2023-11-22

    Frozen ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC recalled Ferrero Rocher ice-cream base distributed in Florida due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. Consumers should not consume this product if allergic to these substances.

    Product
    Ferrero Rocher, Ice-cream base, Hazelnut, Nutella, Penuts, Cacao, Rich Chocolate, Artificial flavoring., DISTRIBUTED BY: PARADISE FLAVORS LLC. 4oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0432-2024·2023-11-22

    Paradise Flavors Strawberries and Cream ice cream base recalled for undeclared milk allergen

    Paradise Flavors LLC is recalling Strawberries and Cream ice cream base (4 oz) due to undeclared milk allergen. Approximately 86 units from the latest production were distributed in Florida.

    Product
    Strawberries and Cream, ice-cream base, natural flavoring. Paradise Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0424-2024·2023-11-22

    Mint Chocolate Chip Ice Cream Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC is recalling 112 units of Mint Chocolate Chip ice cream for containing undeclared milk and food color additives (FD&C yellow #5, blue #1, red #40). The product was distributed in Florida.

    Product
    MINT CHOCOLATE CHIP, Ice-cream base, Chocolate chips, Artificial Flavoring, Artificial color. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states