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.

4701–4725 of 52939

  • HighFDA (Devices)·Z-1544-2025·2025-04-16

    DNA Labeling Kit Component Affected by Chromosome Aberration

    Agilent's GenetiSure Dx Labeling Kit contains a human reference DNA component with a mosaic aberration that may cause false test results and diagnosis delays in genetic testing.

    Product
    GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1532-2025·2025-04-16

    Omnicell IVX Station Reconstitution Transfer Sets Recall

    Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.

    Product
    IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1529-2025·2025-04-16

    Beckman Coulter DxI 9000 Immunoassay Analyzer Electrical Short Risk

    Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzer units due to ground screws on PCB boards that may cause electrical shorts, leading to smoke and delayed patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1518-2025·2025-04-16

    FilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures

    BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.

    Product
    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1530-2025·2025-04-16

    Wayson Hydrocolloid Bandages Recalled Due to Sterility Compromise Risk

    Medline Industries is recalling multiple Wayson Hydrocolloid bandage models due to potential compromise of device sterility. The recalled products were distributed nationwide in the US and internationally.

    Product
    Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0310-2025·2025-04-16

    Venlafaxine Tablets 75 mg Recalled for Foreign Metal Material

    Zydus Pharmaceuticals is recalling Venlafaxine 75 mg tablets due to a complaint of a metal shaving found embedded in a tablet. The recall affects 13,128 bottles distributed nationwide.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0699-2025·2025-04-16

    Lillie's Q Buffalo Wing Sauce recalled for undeclared milk allergen

    OLD WORLD SPICES & SEASONING, INC is recalling Lillie's Q Buffalo Wing Sauce (13.5 oz bottles, Lot #002125 and others) because milk, present as a sub-ingredient in butter, is not declared on the label or in the "Contains" statement.

    Product
    Lillie's Q Buffalo Wing Sauce. Net wt. 13.5 oz, UPC 810069510972, Case label: Lillie's Q Buffalo Wing Sauce, Item # FGLOL422 Lot # 002125, 6/13.5 oz, UPC 10810069510979, BEST BY: JAN/21/2026
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0695-2025·2025-04-16

    Las Ollas Botana Mix snack recalled for undeclared allergens

    Kedake Inc is recalling Las Ollas Botana Mix snack (2lbs bags) due to undeclared sesame, soy, wheat, and food colorings (Yellow No. 5, Yellow No. 6, Red No. 6) that may pose a risk to consumers with allergies.

    Product
    Las Ollas Botana Mix snack, 2lbs, item #1516, # 1056, UPC# 880342001855
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0347-2025·2025-04-16

    OTC Acetaminophen and Ibuprofen Tablets Recalled for Manufacturing Quality Deviations

    Glenmark Pharmaceuticals is recalling acetaminophen-ibuprofen tablets due to manufacturing quality deviations. No illnesses reported. Distributed nationwide via Amazon and Walmart.

    Product
    ACETAMINOPHEN, IBUPROFEN — ACETAMINOPHEN, IBUPROFEN (ACETAMINOPHEN, IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2025·2025-04-16

    BD Pyxis automated dispensing cabinets recalled for software dosing bug

    CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.

    Product
    BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V227000·2025-04-15

    Audi Recalls 2022-2023 E-TRON GT Models for Passenger Air Bag Fault

    Audi is recalling 2022-2023 RS E-TRON GT and E-TRON GT vehicles because a wiring fault may deactivate the front passenger air bag, increasing injury risk in a crash.

    Product
    AUDI — AUDI RS E-TRON GT, E-TRON GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V246000·2025-04-15

    Alfa Romeo Tonale and Dodge Hornet displays may omit rearview image

    Chrysler is recalling certain 2023-2025 Alfa Romeo Tonale and Dodge Hornet vehicles because the display module may not show the rearview camera image, failing FMVSS 111.

    Product
    ALFA ROMEO — ALFA ROMEO, DODGE TONALE PHEV, HORNET, TONALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25T006000·2025-04-15

    Goodyear Recalls Cooper Tires Missing Identification Codes

    Goodyear is recalling specific Cooper Discoverer Stronghold AT tires because they lack the required week and year code. This prevents owners from determining the tire's age or recall status.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V244000·2025-04-14

    Maserati Recalls 2024 Granturismo for Detaching Tire Label

    Maserati is recalling 2024 Granturismo vehicles because the tire label may detach, potentially leading to vehicle overload and increased crash risk.

    Product
    MASERATI — MASERATI GRANTURISMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V245000·2025-04-14

    Forest River removable trailer steps may detach while in use

    Forest River is recalling certain 2024-2025 trailers with a removable step assembly because the clip-on bracket mounting bolt may allow the steps to detach in use.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN CASCADE, SANDPIPER, CAMPSITE RESERVE, IMPRESSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V239000·2025-04-11

    Ford Explorer powertrain control modules may reset while driving

    Ford is recalling certain 2025 Explorer vehicles because the powertrain control module may reset while driving, which can damage the park system or cause an engine stall.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V237000·2025-04-11

    Ford Ranger global window closing repair was performed incorrectly

    Ford is recalling certain 2024 Ranger and Lincoln Nautilus vehicles previously repaired incorrectly under recall 24V-597, because windows may not reverse on detecting an object.

    Product
    FORD — FORD, LINCOLN RANGER, NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-04112025-01·2025-04-11

    USDA Issues Public Health Alert for Soup and Bowl Products Due to Wood Contamination

    USDA FSIS issued a public health alert for various soup and bowl products potentially contaminated with wood in cilantro. Consumers in Illinois, Indiana, Michigan, and Ohio should not consume these items.

    Product
    FSIS Issues Public Health Alert for Various Soup & Bowl Products Due to Possible Extraneous Material Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·25221·2025-04-10

    Multifunctional Puzzle Crab Toys with Magnets Recalled for Ingestion Hazard

    About 600 magnetic puzzle crab toys sold on Walmart.com are recalled because swallowed magnets can cause serious digestive injury. Consumers should stop using them immediately and request a full refund.

    Product
    Multifunctional Puzzle Crab Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25219·2025-04-10

    Long-Haul ATV fuel containers recalled for non-child-resistant closure

    Long-Haul 5L ATV fuel containers sold on Amazon.com lack required child-resistant closures, posing burn, fire, and poisoning risks to children. About 815 units sold from January 2023 through October 2024 are recalled.

    Product
    Long-Haul 5L ATV Gas Cans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25215·2025-04-10

    Fisher-Price Brunch & Go Stroller Toys Recalled for Choking Hazard

    Fisher-Price is recalling about 253,000 Brunch & Go Stroller Toys because the egg component can crack and create choking hazards. No injuries have been reported; consumers should immediately stop use and request a free replacement.

    Product
    Brunch & Go Stroller Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide