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.

12026–12050 of 88183

  • HighFDA (Devices)·Z-2520-2024·2024-08-14

    Medical Procedure Kit Recalled Over Potential Sterilization Compromise

    American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Special Procedure Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2024·2024-08-14

    Automated dispensing cabinet software issue causes incorrect medication bin labels

    CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.

    Product
    BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2024·2024-08-14

    Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2024·2024-08-14

    American Contract Systems Spine Pack kits recalled for insufficient sterilization aeration

    American Contract Systems is recalling Spine Pack convenience kits (Lot 980241) due to incomplete post-sterilization aeration. The affected kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Spine Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2024·2024-08-14

    American Contract Systems surgical kits recalled for sterilization defect

    American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.

    Product
    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2024·2024-08-14

    Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels

    BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2024·2024-08-14

    Luminos dRF Max X-ray Display Support Arm May Unintentionally Lower

    Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.

    Product
    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1720-2024·2024-08-14

    Panaderia Guatemex Churros Recalled Due to Undeclared Soy Allergen

    Panaderia Guatemex is recalling churros with undeclared soy allergen distributed in GA, KY, and TN. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Churros packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2511-2024·2024-08-14

    Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities

    Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.

    Product
    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2024·2024-08-14

    Biopsy Drape Pack sterilization failure recall from American Contract Systems

    American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.

    Product
    American Contract Systems Biopsy Drape Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1619-2024·2024-08-14

    Urban River Spirits Grapefruit Mixer Recalled for Potential Under-Processing

    Urban River Spirits is recalling Ruby-Red Grapefruit Mixer due to potential under-processing of the non-alcoholic beverage made in an unlicensed facility. No illnesses have been reported.

    Product
    Ruby-Red Grapefruit Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1626-2024·2024-08-14

    Non-alcoholic cocktail mixer recalled for potential under-processing

    Urban River Spirits is recalling Lush Lavender & Wildberry Spritz non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.

    Product
    Lush Lavender & Wildberry Spritz is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1634-2024·2024-08-14

    Urban River Spirits Cocktail Mixer Recalled for Potential Under-Processing

    Urban River Spirits Crisp Cucumber and Mint cocktail mixer recalled due to production in an unlicensed, uninspected facility. Potential under-processing poses a safety risk.

    Product
    Crisp Cucumber and Mint is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1617-2024·2024-08-14

    Non-Alcoholic Beverage Mixer Recalled for Potential Under-Processing Concerns

    Urban River Spirits is recalling Watermelon Lemonade Splash non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed, uninspected facility, raising food safety concerns.

    Product
    Watermelon Lemonade Splash is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1635-2024·2024-08-14

    Cinnamon Infused Syrup Recalled from Unlicensed Manufacturing Facility

    Urban River Spirits is recalling 3,876 bottles of Cinnamon Infused Simple Syrup due to manufacturing in an unlicensed, uninspected facility with potential under-processing concerns.

    Product
    Cinnamon Infused Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2505-2024·2024-08-14

    Surgical Laser System Recalled Due to Wireless Footswitch Pairing Difficulties

    Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.

    Product
    Soltive Pro SuperPulsed Laser System, Model TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1615-2024·2024-08-14

    Urban River Spirits Raspberry Lemon Mixer recalled for potential under-processing

    Urban River Spirits is recalling Raspberry Lemon Mixer because the product was manufactured in an unlicensed and uninspected facility. The recall concerns potential under-processing issues.

    Product
    Raspberry Lemon Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0627-2024·2024-08-14

    Acetaminophen 500mg Rapid Release Gelcaps Recalled for Carton Label Mix-up

    Walgreen Co. is recalling Acetaminophen 500mg Rapid Release Gelcaps (Lot #31670346AA, expires 12/31/2026) due to incorrect carton labeling. The 21,192 affected bottles were distributed to retailers in Illinois.

    Product
    Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1628-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled Due to Potential Under-Processing in Unlicensed Facility

    Urban River Spirits' Spicy Orange and Mango Fusion non-alcoholic cocktail mixer is recalled due to production in an unlicensed, uninspected facility with potential under-processing. Approximately 3,876 bottles were distributed across 11 states.

    Product
    Spicy Orange and Mango Fusion is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1638-2024·2024-08-14

    Brown Sugar Simple Syrup Recalled for Potential Under-Processing

    Urban River Spirits is recalling Brown Sugar Simple Syrup due to manufacture in an unlicensed, uninspected facility with potential under-processing concerns.

    Product
    Brown Sugar Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1621-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled for Potential Under-Processing Issue

    Urban River Spirits is recalling 3876 bottles of Blackberry and Lime Mixer manufactured in an unlicensed, uninspected facility with potential under-processing. Consumers across 11 states should not consume the product.

    Product
    Blackberry and Lime Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1623-2024·2024-08-14

    Keep It Spicy cocktail mixer recalled for potential under-processing

    Urban River Spirits recalled Keep It Spicy Pear & Jalapeno Mixer because it was produced in an unlicensed, uninspected facility with potential under-processing. The product was distributed across 11 states.

    Product
    Keep It Spicy Pear & Jalapeno Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1636-2024·2024-08-14

    Vanilla Infused Simple Syrup Recalled Over Potential Under-Processing Risk

    Urban River Spirits Vanilla Infused Simple Syrup is being recalled. The product was made in an unlicensed and uninspected facility with potential under-processing, raising food safety concerns.

    Product
    Vanilla Infused Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
    Category
    Food
    Distribution
    11 states