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.

15826–15850 of 88183

  • SevereFDA (Food)·F-0431-2024·2023-11-22

    Paradise Flavors Pina Colada Ice Cream Base Recalled for Undeclared Allergens

    Paradise Flavors is recalling 120 units of Pina Colada ice-cream base in 4 oz packages due to undeclared milk and tree nuts allergens, and undeclared color additives. Consumers with allergies should not consume this product.

    Product
    Pina Colada, ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0423-2024·2023-11-22

    UNICORN Ice-Cream Base Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors LLC is recalling 216 units of UNICORN Ice-Cream Base distributed in Florida due to undeclared milk allergen and color additives (FD&C red #5, blue #1, red #3, red #40, yellow #5).

    Product
    UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0459-2024·2023-11-22

    Orange Creamcycle frozen pops recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling Orange Creamcycle frozen pops due to undeclared milk allergen and undeclared color additives. The product was distributed in Florida and may pose health risks to consumers with milk allergies.

    Product
    ORANGE CREAMCYCLE, Filtered water, natural flavoring, artificial color, citric acid and carboxymethylcellulose, PARADISE FLAVORS. 4 OZ, 120ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0457-2024·2023-11-22

    Frozen ice cream base recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling Chunky Mango frozen ice cream base for containing undeclared milk allergen and color additives. The product poses a health risk to consumers with milk allergies.

    Product
    CHUNKY MANGO, ice-cream base, natural flavoring, artificial flavor and color. 4 OZ, 120ml. DISTRIBUTED BY: Paradise Flavors LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0438-2024·2023-11-22

    Frozen Chocolate Razzberry Cake Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC is recalling Chocolate Razzberry Cake (Gancito) frozen dessert due to undeclared milk, peanuts, soy, and wheat allergens, plus undeclared color additives.

    Product
    CHOCOLATE RAZZBERRY CAKE (GANCITO). INGREDIENTS: Icecream base, Natural flavor, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0441-2024·2023-11-22

    Frozen Yogurt Recalled Due to Undeclared Milk and Other Allergens

    YOGOBERRY frozen yogurt (4 oz pouches) is recalled due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. The product was distributed in Florida.

    Product
    YOGOBERRY (YOGURT WITH FRUITS), Ice cream, Mix Berries, Granola, Honey, Citric acid., PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0427-2024·2023-11-22

    Butter pecan ice cream recalled for undeclared allergens and color additives

    Paradise Flavors LLC is recalling BUTTER PECAN ice cream due to undeclared milk and tree nut allergens and undeclared color additives. The product was distributed domestically in Florida.

    Product
    BUTTER PECAN, Ice-cream base, Natural flavor, graham crackers, artificial color, citric acid, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0446-2024·2023-11-22

    Blackberry Cheesecake Ice Cream Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling Blackberry Cheesecake ice cream (4 oz) due to undeclared milk, soy, and wheat allergens. The product was distributed in Florida.

    Product
    BLACKBERRY CHEESECAKE, Ice-cream base, Natural Flavor, Cheese, Butter, crackers., 4 oz (120 ML), PARADISE FLAVORS LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0456-2024·2023-11-22

    Paradise Flavors Frozen Key Lime Pie Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors frozen key lime pie contains undeclared allergens (milk, soy, wheat) and color additives (FD&C yellow #5, blue #1, red #40). Consumers with allergies should not consume this product.

    Product
    KEY LIME PIE, PARADISE FLAVORS, 9601 Overseas Hwy, Marathon FL. 33050. 4 OZ. 120ml. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0448-2024·2023-11-22

    Peanut Butter Ice-Cream Base Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling peanut butter ice-cream base distributed in Florida due to undeclared allergens (milk, peanut, soy, and wheat) not listed on the label.

    Product
    PEANUT BUTTER/MAZAPAN, Ice-cream base, Natural Flavor, Artificial Color, sea salt., Distributed by PARADISE FLAVORS LLC, 4 OZ. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0426-2024·2023-11-22

    Vanilla Ice Cream Base Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC is recalling vanilla ice cream base due to undeclared milk allergen and color additives. Consumers with milk allergies should not use this product.

    Product
    VANILLA, Ice-cream base, Natural flavor, artificial flavor and coloring. Distributed By Paradiose Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0444-2024·2023-11-22

    Chocolate ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC is recalling Chocolate with Almonds ice-cream products due to undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with these allergies should discard the product.

    Product
    CHOCOLATE WITH ALMONDS, ice-cream base, chocolate powder, natural flavoring, PARADISE FLAVORS, 4oz, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0430-2024·2023-11-22

    Paradise Flavors Sweet Corn Ice Cream Mix Recalled for Undeclared Milk and Color Additives

    Paradise Flavors recalls Sweet Corn ice cream mix distributed in Florida for undeclared milk allergen and color additives. Consumers with milk allergies risk allergic reaction from this product.

    Product
    SWEET CORN/ELOTE, Ice cream mix, natural flavoring, sea salt. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2024·2023-11-22

    Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus

    Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.

    Product
    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2024·2023-11-22

    IBA Proton Therapy System Patient Positioning Can Move Unexpectedly

    The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.

    Product
    IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2024·2023-11-22

    Medline Blood Culture Collection Kits Recalled for Expired Internal Components

    Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.

    Product
    ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0414-2024·2023-11-22

    Full Spectrum Hemp Oil Gummies recalled for undeclared sunflower allergen

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sunflower allergen in the product. Affected products (Lot 081321) were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Fruit Punch, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0300-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.

    Product
    LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure

    Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.

    Product
    LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0409-2024·2023-11-22

    Frozen Tuna Ground Meat Recalled Due to Bacterial Contamination and Histamine

    Takumi brand frozen tuna ground meat is being recalled due to bacterial contamination (E. coli, coliforms) and elevated histamine. The product was distributed in CA, NV, TX, and NC in August-September 2021.

    Product
    Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fiber boxes, net wt. 11 lbs. per box. individual units were sold by weight at the point of sale. Product of Fiji, and imported by Tokai Denpun USA INC. Bellevue, WA. Vacuum package label is…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0301-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2024·2023-11-22

    LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins

    Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.

    Product
    LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2024·2023-11-22

    Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions

    Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.

    Product
    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0319-2024·2023-11-22

    CT Scanner Software Bug May Cause Gantry to Move to Wrong Position

    Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide