The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14401–14425 of 22168

  • 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 (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-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-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-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-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 (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 (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 (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-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 (Food)·F-1367-2023·2023-08-16

    Bellingham Pasta Co Linguine Recalled Due to Undeclared Wheat Allergen

    Bellingham Pasta Co is recalling 190 packages of Semolina Lemon Black Pepper Linguine because the label declares semolina flour but fails to declare wheat as an ingredient, posing a risk to consumers with wheat allergies.

    Product
    Semolina Lemon Black 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, Water, Egg, Lemon, Black Pepper, dusted with Brown Rice Flour. Keep Refrigerated
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1390-2023·2023-08-16

    Sweet Alchemy ice cream recalled for undeclared allergens

    Sweet Alchemy Strawberry Rhubarb Crisp ice cream sold in Washington has been recalled because its labels do not declare the presence of milk, egg, and wheat allergens.

    Product
    Sweet Alchemy Strawberry Rhubarb Crisp 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 (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-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 (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-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 (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-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 (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 (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-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 (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-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