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.

17101–17125 of 88183

  • 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-2355-2023·2023-08-16

    LINK MP Hip Stem Trial Instruments difficult to remove after implantation

    The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2366-2023·2023-08-16

    Medline Total Hip Kit Recalled for Expired Prep Solution

    Medline is recalling the Total Hip Kit (REF DYNJ903275S) because the included prep solution expires before the kit itself expires. Sixteen kits with lot code 23CDC733 were distributed nationwide.

    Product
    Total Hip Kit, REF DYNJ903275S; surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2023·2023-08-16

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

    Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1397-2023·2023-08-16

    Sweet Alchemy Vegan Raspberry Chip Ice Cream Recalled for Missing Allergen Declarations

    Sweet Alchemy Vegan Raspberry Chip ice cream sold in Washington State lacks allergen declarations for Coconut and Soy on its labels. Allergic consumers should not consume this product.

    Product
    Sweet Alchemy Vegan Raspberry Chip 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 (Food)·F-1388-2023·2023-08-16

    Sweet Alchemy Strawberry ice cream recalled for undeclared allergens

    Sweet Alchemy Strawberry ice cream in pints fails to declare Egg and Milk allergens on labels. Fifteen pints distributed in Washington are affected.

    Product
    Sweet Alchemy Strawberry 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-1376-2023·2023-08-16

    Bellingham Pasta Co Recalls Semolina Linguine for Undeclared Wheat

    Bellingham Pasta Co recalls Semolina Roasted Red Pepper Linguine (14oz) due to undeclared wheat allergen. The product was distributed in Washington state.

    Product
    Semolina Roasted Red Pepper Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Egg, Red Sweet Peppers, Water, Sea Salt, Citric Acid, Whole Grain Brown Rice.…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2347-2023·2023-08-16

    LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force

    LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2023·2023-08-16

    Hip implant trial stem: increased removal force may extend surgery

    Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2023·2023-08-16

    LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction

    Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1372-2023·2023-08-16

    Pasta Recalled for Undeclared Wheat Allergen in Mixed Flavors Case

    Bellingham Pasta Co recalls 168 packages of mixed flavors pasta in Washington due to undeclared wheat allergen in semolina flour. Consumers with wheat allergies may experience allergic reactions.

    Product
    Pasta - Mixed Flavors case. Firm did not provide label.
    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 (Devices)·Z-2352-2023·2023-08-16

    LINK MP Hip Stem trial instruments may require increased removal force during surgery

    LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
    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
  • HighFDA (Food)·F-1394-2023·2023-08-16

    Sweet Alchemy Vegan Lemon Pie Ice Cream Lacks Required Allergen Labeling

    Sweet Alchemy Vegan Lemon Pie ice cream sold in Washington lacks required allergen labeling for coconut and wheat. Consumers with these allergies should not consume this product.

    Product
    Sweet Alchemy Vegan Lemon Pie 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-2344-2023·2023-08-16

    Olympus Endoscope Reprocessor Labeling Revised for Compatibility and Sterilization Parameters

    Olympus is revising labeling for its OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors due to incompatible endoscope models and incorrect sterilization parameters in previous labeling. The revisions remove two endoscope models from the compatibility list and correct gas sterilization concentration requirements.

    Product
    Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2393-2023·2023-08-16

    Ellacor System recalled for bearing adhesive defect risk

    The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.

    Product
    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2023·2023-08-16

    Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect

    Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical procedures.

    Product
    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1377-2023·2023-08-16

    Semolina Pappardelle Pasta Lacks Wheat Allergen Label Declaration

    Bellingham Pasta Co is recalling Semolina Pappardelle pasta because the label declares semolina flour but fails to declare wheat, a common allergen. The recall affects 199 packages distributed in Washington state.

    Product
    Semolina Pappardelle, 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 00220 0.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1381-2023·2023-08-16

    Eclipse Foods Frozen Caramel Butter Pecan Cups Recalled for Potential Ink Pen Pieces

    Eclipse Foods is recalling 14 fl oz Caramel Butter Pecan Cups for the potential presence of ink pen pieces and foreign objects. The affected product was distributed in seven states.

    Product
    Caramel Butter Pecan Cup 14 fl oz. cup (8 per case) Paper cup with paper lid Brand: Eclipse Foods UPC: 810049270490 Frozen
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1396-2023·2023-08-16

    Sweet Alchemy Vegan Chocolate Ice Cream Recalled for Undeclared Peanut and Coconut Allergens

    Sweet Alchemy Ice Creamery is recalling 27 pints of its Vegan Nutty for Chocolate ice cream due to missing ingredient and allergen declarations on the label. The product contains peanut and coconut but does not declare these common allergens.

    Product
    Sweet Alchemy Vegan Nutty for Chocolate 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 (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 (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 (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-2340-2023·2023-08-16

    Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision

    Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.

    Product
    VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
    Category
    Medical Device
    Distribution
    Distributed nationwide