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.

6201–6225 of 52958

  • HighFDA (Drugs)·D-0078-2025·2024-12-11

    Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity

    Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.

    Product
    Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2025·2024-12-11

    GE Healthcare CT Systems Recalled Due to Progressive Image Rotation

    GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.

    Product
    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0237-2025·2024-12-11

    Sysco Low Cal Lemonade Recalled for Metal Fragments

    DYMA Brands is recalling Sysco Low Cal Lemonade (8.6 oz pouches) due to metal fragments introduced during production. The product was distributed across 29 states.

    Product
    SYSCO LOW CAL LEMONADE, NET WT. 8.6OZ, Case UPC 00734730132648, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0615-2025·2024-12-11

    GE Healthcare CT Operator Console Update: Images May Rotate Progressively

    GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0582-2025·2024-12-11

    Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect

    Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.

    Product
    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0601-2025·2024-12-11

    GE Healthcare Optima 520 CT systems recalled for image rotation

    GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0644-2025·2024-12-11

    MEDLINE circumcision kits recalled due to defective smoke evacuation component

    MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2025·2024-12-11

    X-ray system hand switch may fail, risking unintended radiation exposure

    Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.

    Product
    Ziehm Vision system, x-ray, tomography, computed.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0103-2025·2024-12-11

    Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall

    AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V918000·2024-12-10

    Jeep Renegade Bumper Reverse Light Assembly Recalled for Reduced Backup Visibility

    Chrysler is recalling 2021-2023 Jeep Renegade vehicles with incorrect bumper reverse light assemblies that may reduce backing visibility. The faulty lights could fail to alert other drivers and pedestrians, increasing crash risk.

    Product
    JEEP — JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V916000·2024-12-10

    Grand Design Momentum Fifth Wheel Trailer Step Defect Recall

    Grand Design is recalling 2023-2025 Momentum fifth wheel trailers because the interior step base may not adequately support the step tread, which could detach and cause trip and fall injuries. Dealers will replace the step components free of charge.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V915000·2024-12-09

    Kenworth and Peterbilt Trucks Recalled for Faulty Electronic Control Units

    PACCAR is recalling 2021-2025 Kenworth and Peterbilt commercial trucks with defective electronic control units that may fail due to electrical interference, potentially disabling critical safety systems including ABS, traction control, and electronic stability control.

    Product
    KENWORTH — KENWORTH, PETERBILT T440, 520, 579, T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V911000·2024-12-05

    2025 Lexus NX recalled for loose brake caliper and wheel bearing bolts

    Toyota is recalling 2025 Lexus NX vehicles with loose brake caliper and wheel bearing bolts that may cause brake fluid leaks or wheel detachment. Either condition increases the risk of a crash.

    Product
    TOYOTA — TOYOTA, LEXUS RAV4, NX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25059·2024-12-05

    QVC recalls 1.1 million Temp-tations oven gloves due to burn hazard

    QVC is recalling about 1.1 million pairs of Temp-tations oven gloves that can fail to protect from heat, causing a burn hazard. The company received 162 reports of insufficient protection, including 92 reports of minor burns.

    Product
    Temp-tations Oven Gloves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25703·2024-12-05

    Polaris RZR XP Off-Road Vehicles Recalled Due to Fire Hazard

    Polaris is recalling about 21,000 RZR XP 1000 and XP 4 1000 recreational off-road vehicles because the battery terminal cover can be damaged by the seat base, exposing the battery post and creating a fire hazard. No injuries have been reported.

    Product
    Model Year 2024-2025 RZR XP 1000 and XP 4 1000 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25702·2024-12-05

    Polaris Recalls 2024 Ranger and Bobcat Off-Road Vehicles for Seat Belt Defect

    Polaris recalled about 2,500 Model Year 2024 Ranger and Bobcat vehicles with a defective passenger side seat belt anchor weld. Consumers should immediately stop carrying passengers and contact an authorized dealer for free repair.

    Product
    Model Year 2024 Ranger Recreational Off-Road Vehicles (ROVs) and ProXD and Bobcat Utility Task Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25060·2024-12-05

    Fireproof Gun Safes Recalled for Locking Mechanism Failure Risk

    Academy Sports + Outdoors is recalling about 6,100 Redfield 12- and 18-gun fireproof safes because mechanical locking plates can fail, potentially allowing unauthorized access. No injuries have been reported.

    Product
    Redfield 12- and 18-Gun Fireproof Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V909000·2024-12-05

    2025 BMW X3 suspension bearing may crack, affecting vehicle control

    BMW is recalling certain 2025 X3 vehicles due to a potential defect in the front suspension bearing. The bearing may crack, causing loss of vehicle handling and control, increasing crash risk.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V910000·2024-12-05

    BMW Recalls 2025 X4 Models Due to Roof Frame Crack Risk

    BMW is recalling 2025 X4 vehicles because a crack in the roof frame may damage the head air bag during deployment, increasing injury risk.

    Product
    BMW — BMW X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25057·2024-12-05

    Scented candles recalled due to fire and laceration hazards

    Vacation Inc. recalls about 13,000 units of Black Label Scented Candles due to flame overheat causing glass breakage and creating fire and laceration risks. No injuries have been reported, but consumers should stop using the product immediately.

    Product
    The Legendary 'VACATION' by Vacation Black Label Scented Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide