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.

12001–12025 of 53044

  • 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-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-2350-2023·2023-08-16

    Hip stem trial instruments recalled due to excessive removal force

    LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2023·2023-08-16

    Angiography systems recalled due to thermal overload in cable connectors

    Siemens ARTIS icono floor angiography systems may experience thermal overload in cable connectors during fluoroscopy, causing burning smell and loss of imaging capability. The recall affects 7 units worldwide.

    Product
    ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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-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-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 (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-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-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-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-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-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 (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 (Food)·F-1400-2023·2023-08-16

    Fresh Creative Foods Caesar Salad Kit Recalled for Potential Deer Feces Contamination

    Fresh Creative Foods Caesar Salad Kit is being recalled due to potential contamination with deer feces. The recall affects 1,210 cases distributed to one facility in Illinois.

    Product
    Fresh Creative Foods Caesar Salad Kit; 3.30 lbs per bag; film bags, individually sealed inside cardboard case; total package size: 6.6 lbs (2 - 3.3 lbs bags); PERISHABLE. KEEP REFRIGERATED
    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 (Food)·F-1375-2023·2023-08-16

    Bellingham Pasta Semolina Spinach Fettuccine Recalled for Undeclared Wheat Allergen

    Bellingham Pasta Co. is recalling 38 packages of Semolina Spinach Fettuccine sold in Washington because the label does not declare wheat, a major allergen present in the product.

    Product
    Semolina Spinach 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, Organic Spinach Powder, dusted with Brown Rice Flour. Keep Refrigerated. UPC…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2348-2023·2023-08-16

    Medical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk

    Waldemar Link GmbH recalls LINK MP Monoblock hip stem trial instruments due to increased removal force requirements after impaction, which may prolong surgery or require procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1378-2023·2023-08-16

    Semolina linguine pasta recalled for undeclared wheat allergen

    Bellingham Pasta Co is recalling semolina linguine due to missing wheat allergen declaration on the label. Consumers with wheat allergies may be at risk.

    Product
    Semolina 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, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00204 0.
    Category
    Food
    Distribution
    1 state