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.

8001–8025 of 88183

  • HighFDA (Food)·F-0808-2025·2025-05-21

    Dixit Foods Sabudana Khichadi Recalled for Undeclared Milk and Peanut Allergens

    Dixit Foods Sabudana Khichadi (200 g) is recalled due to undeclared milk and/or peanut allergens. The product may pose a serious risk to consumers with allergies to these ingredients.

    Product
    Dixit Foods, Sabudana Khichadi, Net Wt. 200 g, Ingredients: Sago (Sabudana), Crushed Groundnuts, Sugar, DesiGhee, Salt, Green Chilli, Cumin Seeds. Allergen Information: May contain Peanuts, Treenuts, Wheat, Sesame, Mustard
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1748-2025·2025-05-21

    Abbott Alinity m Resp-4-Plex Amplification Kit Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex Amplification Kit due to reports of reactive negative controls and false positive results in respiratory virus testing.

    Product
    Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2025·2025-05-21

    KliniTray surgical alignment system recalled for microbial contamination risk

    Klinika Medical is recalling the KliniTray tissue resection margin examination board (Model 2001105-F) due to potential microbial contamination. The device was distributed nationwide in Massachusetts.

    Product
    KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2025·2025-05-21

    Pruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals

    LeMaitre Vascular is recalling Pruitt Irrigation Occlusion Catheters (Catalog Numbers 2102-09, E2102-09) due to incomplete sterile barrier seals found during internal testing. The defect affects approximately 26,872 units distributed nationwide and internationally.

    Product
    Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0792-2025·2025-05-21

    Wells Dairy GFGB Vanilla Ice Cream Recalled for Plastic Contamination

    Wells Enterprises is recalling GFGB 12% Vanilla Flavored Ice Cream (3-gallon tubs) because plastic foreign material may be present in the product. Consumers should not consume the product and should contact the company or retailer.

    Product
    GFGB 12% Vanilla Flavored Ice Cream, 3 GAL, Wells Enterprises, INC dba Wells Dairy, Inc Le Mars, IA 51031, UPC: 070640018451, Item: 1435313
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1775-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could contact patients during scanning and cause skin injuries.

    Product
    Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0787-2025·2025-05-21

    Planet Smoothie Frozen Yogurt Recalled for Possible Plastic Foreign Material

    Wells Enterprises is recalling Planet Smoothie ZSA Vanilla Flavored Fat Free Frozen Yogurt (3-gallon tubs) because plastic foreign material may be present in the product.

    Product
    Planet Smoothie ZSA Vanilla Flavored Fat Free Frozen Yogurt, 3 GAL, Wells Enterprises, INC dba Wells Dairy, Inc Le Mars, IA 51031, UPC: 070640005567, Item: 889334
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1781-2025·2025-05-21

    Philips Intera CV MRI Quadrature Body Coil Seal Adhesive Failure Recall

    Philips is recalling Intera CV MRI units (Model 781107) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning, including skin abrasions, lacerations, or tissue damage.

    Product
    Intera CV, Model Number: 781107;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2025·2025-05-21

    Centurion Sterile Weitlaner Retractor recalled for sterile packaging puncture risk

    Medline Industries is recalling Centurion Sterile Weitlaner Retractor 3 x 4 Prong units because the retractors may puncture through the sterile packaging. The product is distributed nationwide.

    Product
    Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2025·2025-05-21

    Philips SmartPath to dStream 3.0T MRI Coil Adhesive Failure Recall

    Philips is recalling SmartPath to dStream 3.0T MRI systems (Model 782145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    SmartPath to dStream for 3.0T, Model Number: 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0783-2025·2025-05-21

    Scooper Hero Ice Cream recalled for possible plastic contamination

    Wells Enterprises is recalling Scooper Hero Ice Cream 3-gallon tubs because plastic foreign material may be present in the product.

    Product
    Scooper Hero Ice Cream, 3 GAL, Wells Enterprises, INC dba Wells Dairy, Inc Le Mars, IA 51031, UPC: 070640050642, Item: 487054
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1776-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Body Coil Seal Failure Recall

    Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.

    Product
    Intera 1.5T Master/Nova, Model Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0802-2025·2025-05-21

    Beijing Soybean Paste Recalled Due to Undeclared Wheat

    May Flower International Inc is recalling Beijing Soybean Paste (8.82 oz/250g packages) because the product contains undeclared wheat, posing a risk to consumers with wheat allergies.

    Product
    Beijing Soybean Paste, packaged in 8.82 ounce/250g red and white packages; Ingredients Soybean, Flour, Salt, Water, Potassium Sorbate; UPC: 6917799000385
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1778-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk

    Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Power/Pulsar, Model Number: 781105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0809-2025·2025-05-21

    Dixit Foods Pohe Recalled for Undeclared Milk and Peanut Allergens

    Dixit Foods Pohe (110 g packages) is recalled due to undeclared milk and/or peanut allergens. The product was distributed in California, Utah, and Washington.

    Product
    Dixit Foods, Pohe, Net Wt. 110 g, Ingredients: Rice Flakes, Groundnuts, Edible Sunflower oil, Sugar, Salt, Green Chilli, Asafoetida, Curry Leaves, Mustard seeds, Turmeric Powder etc, Allergen Information: May contain Peanuts, Treenuts, Wheat, Sesame, Mustard
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1771-2025·2025-05-21

    Philips Intera 0.5T Standard MRI System Quadrature Body Coil Seal

    Philips is recalling the Intera 0.5T Standard MRI system (Model 781101) because the Quadrature Body Coil seal adhesive may fail and create sharp edges that could injure patients during scanning.

    Product
    Intera 0.5T Standard, Model Number: 781101;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0781-2025·2025-05-21

    Wells Dairy Peanut Butter N Fudge Ice Cream Recall Plastic Foreign Material

    Wells Enterprises is recalling Peanut Butter 'N Fudge Ice Cream 3-gallon tubs because plastic foreign material may be present in the product.

    Product
    Peanut Butter 'N Fudge Ice Cream, 3 GAL, Wells Enterprises, INC dba Wells Dairy, Inc Le Mars, IA 51031, UPC: 070640050574, Item: 33429
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0778-2025·2025-05-21

    President Brand Kumquat Slices Recalled for Undeclared Sulfites

    East CK Trading Inc. is recalling President Brand Kumquat Slices because they contain undeclared sulfites. Sulfites are a known allergen that can cause serious reactions in sensitive individuals.

    Product
    PRESIDENT BRAND; Kumquat Slices; NET WT. 8 OZ/227g; EAST CK TRADING INC.; INGREDIENTS: Kumquat slices; packaged in clear plastic jars with UPC 8 10077 20936 3
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0804-2025·2025-05-21

    Blueberry Lemon Scones recalled for undeclared soy allergen

    The Hot Chocolatier - St. Elmo, LLC is recalling Blueberry Lemon Scones sold in bulk bakery boxes because they contain undeclared soy, a common allergen.

    Product
    Blueberry Lemon Scones, bulk packaged in bakery boxes. Products are sold at retail in pastry cases and not individually labeled.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1770-2025·2025-05-21

    Philips Enterprise 1.5T MRI Equipment Quadrature Body Coil Seal

    Philips is recalling Enterprise 1.5T MRI scanners (Model 781145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Enterprise 1.5T, Model Number: 781145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2025·2025-05-21

    Philips Intera 3.0T Quasar Dual MRI Scanner Coil Seal Adhesive Failure

    Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 3.0T Quasar Dual, Model Number: 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2025·2025-05-21

    Philips Intera 1.5T R11 MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T R11 MRI systems because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could contact patients and cause skin injuries.

    Product
    Intera 1.5T R11, Model Number: 781170;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2025·2025-05-21

    Philips Intera 1.0T MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries during patient scanning.

    Product
    Intera 1.0T Omni/Stellar, Model Number: 781102;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0786-2025·2025-05-21

    Quick Blend Vanilla Flavored Ice Cream recalled for plastic contamination

    Wells Enterprises is recalling Quick Blend Vanilla Flavored Ice Cream (3-gallon tubs) because plastic material may be present in the product.

    Product
    Quick Blend Vanilla Flavored Ice Cream, 3 GAL, Wells Enterprises, INC dba Wells Dairy, Inc Le Mars, IA 51031, UPC: 070640050604, Item: 773034
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1743-2025·2025-05-21

    Halyard RAPIDES E-PACK Cardiovascular Procedure Kit Surgical Needle Coating Issue

    AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kits due to a raw material defect in surgical needle coating that may cause diminished performance or coating removal during use.

    Product
    Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide