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.

8951–8975 of 27089

  • ModerateFDA (Food)·F-0064-2025·2024-10-30

    Horizon Organic Ultra Pasteurized Heavy Whipping Cream recalled for potential premature spoilage

    Horizon Organic Dairy is recalling approximately 2,956 cases of Ultra Pasteurized Heavy Whipping Cream (BEST BY 10/22/24) distributed across 14 states due to the potential for premature spoilage during shelf life.

    Product
    Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0025-2025·2024-10-30

    Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations

    Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.

    Product
    OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0043-2025·2024-10-23

    Seasoned Radish Recalled for Undeclared Crustacean Allergen

    Lemonland Food Corp is recalling Item FLD1080A Seasoned Radish due to undeclared shrimp. The product was distributed in Washington; consumers with crustacean allergies should not consume it.

    Product
    Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pepper Powder, Malt Syrup, Salt, Anchovy, Sugar, Garlic, Ginger, Sesame.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0041-2025·2024-10-23

    Perilla Leaves in Soy Sauce recalled for undeclared wheat and fish allergens

    Lemonland Food Corp recalls Item FLD1000BA Perilla Leaves in Soy Sauce due to undeclared wheat and fish allergens on the label. Consumers with these allergies should not consume the product.

    Product
    Item FLD1000BA, Perilla Leaves in Soy Sauce, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Perilla Leaves, Soy Sauce, Sugar
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0036-2025·2024-10-23

    Enjoy Premium Coconut Cookies Recalled for Undeclared Milk Allergen

    KTM Services, Inc. is recalling Enjoy Premium Coconut Cookies sold in Hawaii, Guam, Nevada, and online due to undeclared milk allergen. Consumers with milk allergies should not consume the product.

    Product
    Enjoy Premium Coconut Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0046-2025·2024-10-23

    Octopus Product Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Item FLD2011 Salted and Seasoned Small Octopus because it contains undeclared fish (anchovy), a major allergen. Approximately 70 packages were distributed in Washington state.

    Product
    Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares: Octopus, Salt, Garlic, Ginger, Red Pepper Powder, Green Onion, Syrup, Sesame Seed.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0035-2025·2024-10-23

    Enjoy Premium Taro Cookies recalled for undeclared milk allergen

    Enjoy Premium Taro Cookies contain undeclared milk allergen and were sold in Hawaii, Guam, and Nevada. Consumers with milk allergies should not consume this product.

    Product
    Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0012-2025·2024-10-23

    Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination

    Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.

    Product
    ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0038-2025·2024-10-23

    Potato Salad Recall: Undeclared Egg and Soybean Allergens

    Lemonland Food Corp is recalling potato salad due to undeclared egg and soybean allergens present in the mayonnaise ingredient. The recall affects 120 packages distributed in Washington.

    Product
    Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise, Sugar, Vegetable.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0037-2025·2024-10-23

    Nuts.com recalls S'mores Bites for undeclared milk allergen

    Nuts.com is recalling S'mores Bites due to undeclared milk allergen. Milk chocolate was listed in the product description but omitted from the ingredient list, creating a labeling mismatch.

    Product
    S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Devices)·Z-0047-2025·2024-10-23

    GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen

    Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.

    Product
    GE Heathcare Giraffe OmniBed; neo natal incubator
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0048-2025·2024-10-23

    Seasoned Pepper with Soybean Paste Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Item FLD1020A Seasoned Pepper with Soybean Paste due to undeclared wheat, fish, and crustacean allergens. Consumers with allergies should not consume this product.

    Product
    Item FLD1020A, Seasoned Pepper with Soybean Paste, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Pepper, Soy Bean Paste.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0044-2025·2024-10-23

    Seasoned Dandelion Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Item FLD1070A Seasoned Dandelion due to undeclared fish (anchovy) not listed on the label. Consumers with fish allergies should not consume this product.

    Product
    Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, Salt, Garlic, Soy Sauce, Chili Powder.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0089-2025·2024-10-23

    Cryostat Model CM1950 Lacks Warning on Flammable Spray Use

    Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.

    Product
    Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0049-2025·2024-10-23

    Lemonland Wild Leeks Recalled for Undeclared Wheat and Fish Allergens

    Lemonland Food Corp is recalling Item FLD1040A Wild Leeks distributed in Washington due to undeclared wheat and fish (anchovy) allergens. The product label declares soy sauce but omits mandatory allergen warnings.

    Product
    Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, Soy Sauce.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0031-2025·2024-10-23

    King Harvest Spinach Hummus Recalled for Potential Plastic Fragments

    Pacific Coast Fresh CO is recalling 994 tubs of King Harvest Spinach Hummus due to potential plastic fragments. The hummus was distributed in Oregon and Washington with a use-by date of 10/08/24.

    Product
    King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108 7.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0099-2025·2024-10-23

    Boston Scientific imaging system software error in grid overlay display

    Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2025·2024-10-23

    Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays

    Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.

    Product
    Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2025·2024-10-23

    Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling

    Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.

    Product
    MEDLINE HEART CABG CDS, REF CDS983376R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2025·2024-10-23

    Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects

    Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.

    Product
    Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Adjustment

    Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2025·2024-10-23

    [pending] Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system ut

    Pending LLM rewrite. Source: FDA_DEVICE Z-0107-2025.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Grid Mark Display Error

    Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2025·2024-10-23

    Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays

    Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.

    Product
    Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0039-2025·2024-10-23

    Lemonland Food Corp Recalls Perilla Leaves in Soybean Paste for Undeclared Wheat and Sesame

    Lemonland Food Corp recalls Item FLD1000A Perilla Leaves in Soybean Paste distributed in Washington. The product label omits wheat and sesame seeds, which are present in the product.

    Product
    Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares Perilla Leaves, Soybean Paste.
    Category
    Food
    Distribution
    1 state