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.

15401–15425 of 27263

  • HighFDA (Food)·F-1368-2023·2023-08-16

    Semolina Vegan Rigatoni Pasta Recalled for Undeclared Wheat Allergen

    Bellingham Pasta Co is recalling Semolina Vegan Rigatoni due to undeclared wheat allergen in the semolina flour ingredient.

    Product
    Semolina Vegan Rigatoni, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00234 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1373-2023·2023-08-16

    Semolina Gemelli Pasta Recall for Undeclared Wheat Allergen

    Bellingham Pasta Co. is recalling Semolina Gemelli pasta because the label does not declare wheat, a major allergen, despite wheat being an ingredient. Consumers with wheat allergies should not consume this product.

    Product
    Semolina Gemelli, 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 00227 9.
    Category
    Food
    Distribution
    1 state
  • 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 (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-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-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 (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. Ke
    Category
    Food
    Distribution
    1 state
  • 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 (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 (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-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-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 (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 (Devices)·Z-2361-2023·2023-08-16

    Siemens ARTIS Angiography Systems: Thermal Overload Risk in Cable Connectors

    Siemens has recalled 10 ARTIS angiography systems due to thermal overload hazard in cable connectors. The issue may cause burning smell and loss of imaging functionality, potentially requiring treatment cancellation or system replacement.

    Product
    ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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
  • HighFDA (Food)·F-1387-2023·2023-08-16

    Sweet Alchemy Lemon Custard Ice Cream Recalled Due to Missing Allergen Labeling

    Sweet Alchemy Ice Creamery is recalling Lemon Custard ice cream cups because labels fail to declare ingredients, including the allergens Egg and Milk.

    Product
    Sweet Alchemy Lemon Custard ice cream, distributed in cups. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • 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 (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 (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
  • ModerateFDA (Devices)·Z-2353-2023·2023-08-16

    LINK MP Hip Stem Difficult to Remove After Surgical Implantation

    Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2023·2023-08-16

    Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

    Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2392-2023·2023-08-16

    Canon Medical INFX-8000C Tableside Console PWB Requires Replacement

    Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.

    Product
    INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
    Category
    Medical Device
    Distribution
    Distributed nationwide