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.

15376–15400 of 27263

  • HighFDA (Devices)·Z-2341-2023·2023-08-16

    Olympus LF-P Tracheal Intubation Fiberscope Sterilization and Compatibility Update

    Olympus is updating labeling for 686 LF-P fiberscopes to clarify they are no longer compatible with OER reprocessors and specify new 100% ETO sterilization protocol.

    Product
    Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2023·2023-08-16

    LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal

    Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2023·2023-08-16

    Ingenia Elition S MR System smoke detection interlock vulnerable to operator bypass

    Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite fire hazards.

    Product
    Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1379-2023·2023-08-16

    Bellingham Pasta Bucatini Recalled for Undeclared Wheat Allergen

    Bellingham Pasta Co is recalling Semolina Bucatini pasta because the label fails to declare wheat, a major allergen present in the product. Consumers with wheat allergies risk allergic reaction.

    Product
    Semolina Bucatini, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00225 5.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1374-2023·2023-08-16

    Bellingham Pasta Co Semolina Shells Recalled for Undeclared Wheat Allergen

    Bellingham Pasta Co is recalling Semolina Shells due to undeclared wheat. The product label does not declare wheat, posing a risk to consumers with wheat allergies.

    Product
    Semolina Shells, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00219 4.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2364-2023·2023-08-16

    Medical Device Recall: UroLift Visual Obturator Weld Defect Risk

    The UroLift Visual Obturator has an improperly performed weld that may fracture during use, and the welded area can harbor contamination not removed by standard cleaning. Affected units should not be used.

    Product
    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1391-2023·2023-08-16

    Sweet Alchemy Toasted Black Sesame Ice Cream Lacks Required Allergen Labeling

    Sweet Alchemy Toasted Black Sesame ice cream pints lack required allergen labeling for Egg, Milk, and Sesame. Affected products were distributed in Washington.

    Product
    Sweet Alchemy Toasted Black Sesame ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2394-2023·2023-08-16

    HoverMatt air transfer mattress contains undersized unit, increases injury risk

    Stryker's HoverMatt 39-inch inflatable transfer mattresses contain 34-inch units inside, reducing available support surface. This increases friction during patient transfers and raises the risk of skin tears.

    Product
    HoverMatt, 39" W x 78" L, REF: HM39SPU-B
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-1371-2023·2023-08-16

    Bellingham Pasta Co Recalls Semolina Sheets for Undeclared Wheat Allergen

    Bellingham Pasta Co recalls Semolina Sheets because the product contains wheat but the label does not declare it. Affected packages have best-by dates of 7/12, 7/15, or 7/19.

    Product
    Semolina Sheets, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00218 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2362-2023·2023-08-16

    Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk

    FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.

    Product
    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1393-2023·2023-08-16

    Sweet Alchemy Vanilla Cubed Ice Cream Recall: Missing Allergen Declarations

    Sweet Alchemy Vanilla Cubed ice cream sold in Washington was recalled because labels do not declare ingredients, including the allergens Egg and Milk.

    Product
    Sweet Alchemy Vanilla Cubed ice cream, distributed in cups and pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1395-2023·2023-08-16

    Undeclared coconut allergen in Sweet Alchemy Vegan Monkey Berry Bash ice cream

    Sweet Alchemy Ice Creamery is recalling Sweet Alchemy Vegan Monkey Berry Bash ice cream distributed in Washington due to undeclared coconut allergen on labels. Affected pints have expiration dates from July 30 to August 21, 2023.

    Product
    Sweet Alchemy Vegan Monkey Berry Bash ice cream, coconut-based product, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2342-2023·2023-08-16

    Olympus OER-Pro Endoscope Reprocessor Revised Labeling for Equipment Compatibility

    Olympus revised OER-Pro labeling because two endoscope models (LF-V, LF-P) are no longer compatible. Sterilization parameters and cleaning procedures have also changed.

    Product
    Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1398-2023·2023-08-16

    FDA Recalls Romaine Lettuce Due to Potential Deer Fecal Contamination

    C&E Farms is recalling 8,010 mini-bins of bulk romaine lettuce that may be contaminated with deer feces. The affected lettuce was distributed to retailers in seven U.S. states.

    Product
    Romaine lettuce packed in bulk 45-lb mini-bins
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2395-2023·2023-08-16

    MR Imaging System Smoke Detector Interlock Vulnerable to Bypass via Power Cycling

    Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.

    Product
    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1389-2023·2023-08-16

    Sweet Alchemy Strawberry Rhubarb Crumble Ice Cream Recalled for Undeclared Allergens

    Sweet Alchemy Strawberry Rhubarb Crumble ice cream distributed in Washington has been recalled because labels do not declare ingredients or allergens including Egg, Milk, and Wheat. Consumers with allergies should not consume this product.

    Product
    Sweet Alchemy Strawberry Rhubarb Crumble ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1385-2023·2023-08-16

    Sweet Alchemy Cookies and Cream ice cream recalled for undeclared allergens

    Sweet Alchemy Cookies and Cream ice cream in cups and pints distributed in Washington is recalled for not declaring egg, milk, and wheat allergens on the label.

    Product
    Sweet Alchemy Cookies and Cream ice cream, distributed in cups and pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1386-2023·2023-08-16

    Sweet Alchemy Dough or Die ice cream pints lack allergen labeling

    Sweet Alchemy Dough or Die ice cream pints distributed in Washington lack ingredient and allergen declarations on labels. The product contains Egg, Milk, Soy, and Wheat allergens.

    Product
    Sweet Alchemy Dough or Die ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1392-2023·2023-08-16

    Sweet Alchemy UW Honey Ice Cream Labels Missing Allergen Declarations

    Sweet Alchemy UW Honey ice cream pints distributed in Washington have labels that fail to declare the presence of Egg and Milk allergens. Consumers with allergies to these ingredients should not consume this product.

    Product
    Sweet Alchemy UW Honey ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2397-2023·2023-08-16

    Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass

    Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1370-2023·2023-08-16

    Bellingham Pasta Co Semolina Spaghetti Missing Wheat Allergen Declaration

    Bellingham Pasta Co is recalling Semolina Spaghetti due to a labeling error: the product contains wheat (as semolina flour) but the label does not declare wheat as an allergen. Wheat-allergic consumers are at risk.

    Product
    Semolina Spaghetti, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00200 2.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2357-2023·2023-08-16

    VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells

    ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1369-2023·2023-08-16

    Semolina Fettuccine pasta recalled due to undeclared wheat allergen

    Bellingham Pasta Co is recalling Semolina Fettuccine due to missing wheat allergen declaration on labels. Consumers with wheat allergies should not consume this product.

    Product
    Semolina Fettuccine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00205 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2345-2023·2023-08-16

    Hip Stem Trial Implant May Require Excessive Force During Removal

    A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1384-2023·2023-08-16

    Sweet Alchemy Blackberry Crumble ice cream recalled for undeclared allergens

    Sweet Alchemy Blackberry Crumble ice cream pints lack required ingredient and allergen labeling, specifically failing to declare milk, egg, and wheat allergens.

    Product
    Sweet Alchemy Blackberry Crumble ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state