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.

19576–19600 of 88183

  • HighFDA (Devices)·Z-1280-2023·2023-03-29

    Wearable ECG smartwatch software bug eliminates physician review

    Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.

    Product
    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2023·2023-03-29

    G7 Acetabular Liner Recalled for Size and Label Discrepancy

    Biomet recalled 12 units of its G7 Acetabular System 40mm Size D Liner because the actual implant is a 38mm Size C. The mismatch between outer labeling and the actual implant could result in wrong-size component placement during surgery.

    Product
    G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0637-2023·2023-03-29

    Meito Milk Cocoa Recalled for Undeclared Coconut Allergen

    Daiso California Warehouse is recalling Meito Milk Cocoa (12gX5P, UPC 4902757444709) because coconut allergen is not declared on the label. Consumers with coconut allergies should discontinue use and return the product.

    Product
    Meito Milk Cocoa 12gX5P (1stick bonus pack) UPC: 4902757444709 Made in Japan
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1267-2023·2023-03-29

    DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.

    Product
    Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2023·2023-03-29

    DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect

    DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.

    Product
    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2023·2023-03-29

    Contact Lens Recall: CooperVision Clariti 1-day Toric With Incorrect Power

    CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.

    Product
    Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2023·2023-03-29

    Dofetilide Capsules Recalled for Failed Content Uniformity Specifications

    Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.

    Product
    Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0470-2023·2023-03-29

    Daytrana Methylphenidate Patches Recalled for Defective Delivery System

    Noven Pharmaceuticals is recalling specific lots of Daytrana methylphenidate transdermal patches distributed nationwide because the delivery system is out of specification for shear. The affected lots require patient and healthcare provider attention.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0624-2023·2023-03-29

    Haiyue Preserved Vegetable Product Recalled for Unauthorized Food Additive

    Haiyue Food Nutritional Preserved Vegetable is recalled because it contains cyclamate, an unauthorized food additive in the United States. The FDA Class III recall affects 55 boxes distributed in New York, North Carolina, Florida, and Indiana.

    Product
    Haiyue Food Nutritional Preserved Vegetable
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0247-2024·2023-03-22

    Turkey and Cheddar Oat Hoagie Recalled Due to Listeria Contamination Risk

    Fresh Creative Cuisine recalled its Turkey & Cheddar Oat Hoagie due to potential Listeria monocytogenes contamination. The recall affects approximately 376 units distributed in 11 states from January 24-30, 2023.

    Product
    Fresh Creative Cuisine Black Label, Turkey & Cheddar Oat Hoagie, Net Wt. 7.3 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0191-2024·2023-03-22

    Quick & Fresh Peanut Butter & Jelly Wheat Recalled for Listeria Risk

    Fresh Ideation Food Group is recalling Quick & Fresh Peanut Butter & Jelly Wheat single-serving packages due to potential Listeria monocytogenes contamination. The product was sold from January 24–30, 2023 in multiple Eastern U.S. states.

    Product
    Quick & Fresh, Peanut Butter & Jelly Wheat, Net . Wt. 5.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0200-2024·2023-03-22

    Fresh Creative Cuisine Chicken Flatbread Recalled for Listeria Contamination

    Fresh Creative Cuisine recalled Petite Santa Fe Chicken Flatbread (9 oz) sold January 24-30, 2023, for potential Listeria monocytogenes contamination. Distribution included MD, PA, DE, NY, DC, NJ, NC, CT, SC, VA, and MA.

    Product
    Fresh Creative Cuisine White Label, Petite Sante Fe Chicken Flatbread, Net Wt. 9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0053-2024·2023-03-22

    Quick & Fresh Yogurt Parfait Recalled for Listeria Contamination Risk

    FRESH IDEATION FOOD GROUP is recalling Quick & Fresh Blueberry Low Fat Yogurt Fruit & Granola Parfait cups sold in January 2023 due to potential Listeria monocytogenes contamination.

    Product
    Quick & Fresh, Blueberry Low Fat Yogurt, Fruit & Granola Parfait, Net . Wt. 9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0532-2023·2023-03-22

    Fresh Creative Cuisine Cuban Baguette Recalled for Listeria Monocytogenes

    Fresh Creative Cuisine Cuban Baguettes sold in January 2023 across multiple states have been recalled due to potential Listeria monocytogenes contamination.

    Product
    Fresh Creative Cuisine, Cuban Baguette, Net . Wt. 9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0215-2024·2023-03-22

    Orchard Bistro Quinoa Bowls Recalled for Potential Listeria Contamination

    Fresh Creative Cuisine recalls Orchard Bistro Rustic Italian Quinoa Bowls distributed across 11 states due to potential Listeria monocytogenes contamination in products sold January 24-30, 2023.

    Product
    Orchard Bistro, Rustic Italian Quinoa Bowl, Net Wt. 10.25 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0096-2024·2023-03-22

    Fresh Creative Cuisine French Omelette & Potatoes Recalled for Listeria Risk

    Fresh Creative Cuisine is recalling French Omelette & Potatoes meals sold in January 2023 due to potential Listeria monocytogenes contamination. The recall affects eleven states including Maryland, Pennsylvania, and New York.

    Product
    Fresh Creative Cuisine White Label, French Omelette & Potatoes, Net . Wt. 5.5 Oz. Single Serving, Mylar Wrap, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0074-2024·2023-03-22

    Fresh Creative Cuisine Ciabatta Baguettes Recalled for Potential Listeria Contamination

    Fresh Creative Cuisine is recalling Chicken, Apple & Brie Ciabatta Baguettes sold in January 2023 due to potential Listeria monocytogenes contamination. The affected products were distributed to eleven states.

    Product
    Fresh Creative Cuisine White Label, Chicken, Apple & Brie Ciabatta Baguette, case of 6, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0045-2024·2023-03-22

    Fresh Creative Cuisine Chicken Caesar Salad Recalled for Potential Listeria Contamination

    Fresh Creative Cuisine is recalling Bistro Chicken Caesar Salad due to potential Listeria monocytogenes contamination. The recalled product was sold in 11 states from January 24-30, 2023.

    Product
    Fresh Creative Cuisine White Label, Bistro Chicken Caesar Salad with Dressing, Net Wt. 5.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0484-2023·2023-03-22

    Bistro To Go Grilled Chicken Sandwich Recalled for Listeria Risk

    Fresh Creative Cuisine is recalling Bistro To Go Grilled Chicken & Fontina Cranberry Ciabatta sandwiches due to potential Listeria monocytogenes contamination. The product was sold in eleven states from January 24–30, 2023.

    Product
    Bistro To Go, Grilled Chicken & Fontina Cranberry Ciabatta, Net Wt. 8.75 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0420-2023·2023-03-22

    Enoki Mushrooms Recalled Due to Listeria Contamination

    Jan Fruits, Inc. is recalling Enoki Mushrooms distributed in California and Hawaii due to Listeria monocytogenes contamination. Consumers should discard the product or return it to the retailer.

    Product
    Enoki Mushrooms 200g 50 units per box UPC: 851084 008358 Lot #3779 on outside of box Imported from Taiwan Distributor: Jan Fruits, Inc. 426 Charter Way Vernon, CA 90058
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0506-2023·2023-03-22

    Strawberry Banana Trifle Dessert Recalled for Listeria Risk

    FRESH IDEATION FOOD GROUP is recalling Bistro To Go Strawberry Banana Trifle due to potential Listeria monocytogenes contamination. The affected single-serving cups were sold January 24–30, 2023.

    Product
    Bistro To Go, Strawberry Banana Trifle, Net Wt. 5.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0504-2023·2023-03-22

    Bistro To Go Croissant Sandwich Recalled for Listeria Contamination Risk

    Fresh Ideation Food Group recalls Bistro To Go Smoked Turkey & Swiss Croissant sandwiches due to potential Listeria monocytogenes contamination. The recall affects 390 units distributed to 11 states and DC.

    Product
    Bistro To Go, Smoked Turkey & Swiss Croissant, Net Wt. 7 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0225-2024·2023-03-22

    Smoked Turkey & Havarti Oat Roll Recall Due to Listeria Risk

    Fresh Creative Cuisine is recalling Smoked Turkey & Havarti Oat Rolls due to potential Listeria monocytogenes contamination. Products were sold January 24-30, 2023, and distributed across 11 states.

    Product
    Fresh Creative Cuisine Black Label, Smoked Turkey & Havarti Oat Roll, Net . Wt. 7 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0496-2023·2023-03-22

    Margharita Rustic Flatbread Pizza Recalled for Potential Listeria Contamination

    FRESH IDEATION FOOD GROUP recalled Bistro To Go Margharita Rustic Flatbread Pizza due to potential Listeria monocytogenes contamination. Products were distributed to 11 states from January 24-30, 2023.

    Product
    Bistro To Go, Margharita Rustic Flatbread Pizza, Net Wt. 11.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states