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.

6076–6100 of 52958

  • HighFDA (Devices)·Z-0678-2025·2024-12-18

    Hermes Medical Imaging Software May Cause Incorrect Image Reconstruction

    Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.

    Product
    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0650-2025·2024-12-18

    FDA Recalls DKS Disposable Kerrison System Surgical Instruments

    Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.

    Product
    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Sma
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0671-2025·2024-12-18

    Automated Dispensing Cabinet Software Flaw May Cause Medication Dispensing Errors

    The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.

    Product
    BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24E106000·2024-12-17

    Cummins Recalls Diesel Engines Due to Coolant Leak Risk

    Cummins is recalling specific B6.7 and F3.8 diesel engines because an incorrect rubber elbow in the cooling system can leak hot coolant, posing an injury risk to bystanders.

    Product
    ENGINE AND ENGINE COOLING:COOLING SYSTEM:HOSES/LINES/PIPING/FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V933000·2024-12-17

    2024 VinFast VF8 vehicles recalled for center air bag deployment risk

    VinFast is recalling 2023–2025 VF8 vehicles because the center air bag in the driver's seat may deploy improperly during a side impact crash and strike the driver's arm, increasing injury risk.

    Product
    VINFAST — VINFAST VF 8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E105000·2024-12-17

    Dicor Recalls InVision Three Burner Cooktops Due to Gas Leak Risk

    Dicor is recalling InVision Three Burner Cooktops because a cracked aluminum burner tube may cause a gas leak, increasing the risk of fire.

    Product
    EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V935000·2024-12-17

    Tesla Model 3, Model Y, Cybertruck tire pressure monitoring system malfunction recall

    Tesla is recalling certain 2017–2025 Model 3, 2020–2025 Model Y, and 2024 Cybertruck vehicles because the tire pressure monitoring system warning light may not remain illuminated between drive cycles, failing to warn drivers of low tire pressure.

    Product
    TESLA — TESLA MODEL 3, MODEL Y, CYBERTRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V932000·2024-12-16

    Mitsubishi Fuso Recalls 2024 Rizon Trucks Due to Drive Power Loss Risk

    Mitsubishi Fuso is recalling 2024 Rizon FEC7K and FEC9K trucks because a control unit malfunction may cause loss of drive power, increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO RIZON FEC9K (E18), RIZON FEC7K (E16)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V930000·2024-12-13

    2019-2022 Mercedes-Benz Sprinter instrument cluster may be too bright

    Daimler Vans USA is recalling 2019-2022 Mercedes-Benz Sprinter vehicles. The instrument cluster illumination may be too bright and non-adjustable, making it difficult for drivers to see critical safety information and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V931000·2024-12-13

    Featherlite Recalls 2023-2024 Horse Trailers Due to Fire Risk

    Featherlite is recalling 2023-2024 Living Quarters Horse Trailers because a rubber gas line may overheat and cause a fire. Dealers will install a copper extension free of charge.

    Product
    FEATHERLITE — FEATHERLITE 9807, 7841, 9808, 7821
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V925000·2024-12-12

    2025 Chevrolet Equinox EV Pedestrian Alert Sound System Defect

    General Motors is recalling 7,606 2025 Chevrolet Equinox EV vehicles due to incorrect pedestrian alert sound software that fails to produce sufficient volume. This violates federal safety standards and may increase the risk of pedestrian injury.

    Product
    CHEVROLET — CHEVROLET EQUINOX EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25065·2024-12-12

    Yoto Mini speakers recalled for battery fire and burn hazards

    Yoto Inc. is recalling approximately 251,165 Yoto Mini speakers because the lithium-ion battery can overheat and catch fire. No injuries have been reported, but consumers should stop using the product and contact Yoto for a free battery replacement kit.

    Product
    Yoto Mini speakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25067·2024-12-12

    Wireless Tree Light Controllers Recalled Due to Fire Hazard

    Wireless tree light controllers sold at Walmart, Target, and Cracker Barrel are being recalled because the receiver can overheat and catch fire. Ten overheating incidents and one fire have been reported, with no injuries.

    Product
    Wireless Decorative Tree Light Controllers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25064·2024-12-12

    Wall Teester Bed Crowns Recalled Due to Mounting Tab Failure

    Touch of Class is recalling about 890 Wall Teester Bed Crowns because their welded mounting tabs can weaken and fail, causing the crown to fall from the wall. One injury has been reported.

    Product
    Wall Teester Bed Crowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V921000·2024-12-11

    Gillig Recalls 2023 Low Floor Buses Due to Odometer Defect

    Gillig is recalling 2023 Low Floor diesel-hybrid transit buses because the odometer fails to display mileage in electric mode, potentially delaying critical maintenance.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2025·2024-12-11

    McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect

    McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.

    Product
    McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V923000·2024-12-11

    Suzuki Recalls 2023-2025 Burgman 400 Scooters for Fuel Leak Risk

    Suzuki is recalling 2023-2025 Burgman 400 scooters because a fuel supply hose may contact a vapor hose, causing fuel leaks that increase fire risk.

    Product
    SUZUKI — SUZUKI AN400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2025·2024-12-11

    Diltiazem extended-release capsules recalled for manufacturing impurity

    Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2025·2024-12-11

    X-ray system hand switch may fail under mechanical stress

    The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.

    Product
    Ziehm Solo FD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0101-2025·2024-12-11

    Duloxetine Capsules recalled for manufacturing impurity exceeding FDA interim limit

    Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-duloxetine impurity above recommended interim limits. The affected lots were distributed in Pennsylvania, Ohio, and Puerto Rico.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0573-2025·2024-12-11

    Mobile C-arm hand switch defect may cause unintended X-ray emission

    Ziehm Solo Digital Mobile C-arm devices may have hand switch defects that can cause unintended radiation emission when exposed to impacts or drops. The recalled units have been distributed in the U.S. and Puerto Rico.

    Product
    Ziehm Solo. Digital Mobile C-arm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0613-2025·2024-12-11

    GE Healthcare CT Operator Console Images May Rotate During Scans

    GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states