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.

11251–11275 of 53043

  • HighFDA (Devices)·Z-0049-2024·2023-11-01

    Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure

    Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.

    Product
    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0180-2024·2023-11-01

    Sub Q Recorder Pack components may lose functionality due to improper sterilization

    American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.

    Product
    Sub Q Recorder Pack, REF BPRC87A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23E085000·2023-11-01

    Hollywood Racks Recalls 2022-2023 Destination E Rack Bicycle Carriers

    Hollywood Racks is recalling 2022-2023 Destination E Rack Bicycle Carriers because a component may fail, allowing a bike to detach and become a road hazard.

    Product
    EQUIPMENT:MECHANICAL:CARRIER/RACK recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2024·2023-11-01

    Pregnancy test strips recalled due to manufacturing documentation gaps

    Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.

    Product
    To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
    Category
    Medical Device
    Distribution
    8 states
  • HighNHTSA·23V727000·2023-10-27

    Ford Mustang Brake Fluid Warning System Software Recall

    Ford is recalling 2020-2023 Mustang vehicles because the brake fluid level sensor may fail to illuminate the warning light when brake fluid is low. Drivers could operate the vehicle with insufficient brake fluid, reducing braking performance and increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V723000·2023-10-26

    2024 Subaru Forester Water Pipe Bolts May Loosen, Risk Fire

    Certain 2024 Subaru Forester models have engine water pipe attachment bolts that may loosen, allowing the pipe to leak coolant onto hot engine components and create a fire risk.

    Product
    SUBARU — SUBARU FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V716000·2023-10-26

    Third-row seatbelt buckle defect in 2022–2024 Jeep Wagoneer models

    Chrysler is recalling 2022–2024 Jeep Wagoneer and Grand Wagoneer vehicles because the third-row seatbelt buckles may not fasten properly. Unfastened seatbelts could increase injury risk during a crash.

    Product
    JEEP — JEEP WAGONEER, GRAND WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24706·2023-10-26

    Bobcat and Kubota Stand-On Zero-Turn Lawnmowers Recalled for Crash and Laceration Hazard

    Doosan Bobcat North America is recalling about 830 Bobcat- and Kubota-branded stand-on zero-turn lawnmowers due to a steering system defect that can prevent the control levers from returning to neutral, disabling the operator presence switch and stopping mechanism. This poses crash and laceration hazards.

    Product
    Bobcat-branded and Kubota-branded stand-on zero-turn lawnmowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24705·2023-10-26

    Kawasaki Lawn Mower Engines Recalled Due to Fire and Burn Hazards

    Kawasaki Motors is recalling about 954 lawn mower engines used in Ariens, Gravely, Husqvarna, John Deere, and RedMax brand equipment. A damaged fuel tube due to improper repair workmanship could leak fuel and cause fire or burn injuries.

    Product
    Kawasaki Lawn Mower Engines used in Ariens, Gravely, Husqvarna, John Deere and RedMax brand lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V717000·2023-10-26

    Kenworth W900 and T800 Vehicles Recalled for Unsecured Seat Belt Attachment

    Certain 2018-2024 Kenworth W900 and T800 vehicles may have an additional spacer in the seat belt attachment, causing an unsecured connection. This could prevent the seat belt from properly restraining an occupant during a crash.

    Product
    KENWORTH — KENWORTH T800, W900, T660, T800B
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V725000·2023-10-26

    2023-2024 Nissan Z: Loose Fasteners May Prevent Pop-Up Hood Activation

    Certain 2023-2024 Nissan Z vehicles have loose fasteners in the front bumper reinforcement that may prevent the pop-up engine hood from activating, increasing injury risk in frontal pedestrian crashes. Dealers will tighten the fasteners free of charge.

    Product
    NISSAN — NISSAN Z
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V720000·2023-10-26

    2022 Toyota Highlander Front Bumper Covers May Detach During Operation

    Toyota is recalling certain 2020-2023 Highlander and Highlander Hybrid vehicles because the front bumper covers may come loose or detach during normal operation, potentially becoming a road hazard.

    Product
    TOYOTA — TOYOTA HIGHLANDER, HIGHLANDER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V718000·2023-10-26

    2024 Mazda MAZDA3 and CX-90 Recalled for Camera Display Failure

    Mazda is recalling 2024 MAZDA3 and CX-90 vehicles due to a software error that prevents camera images from displaying, which fails federal rear visibility requirements and increases crash risk.

    Product
    MAZDA — MAZDA MAZDA3, CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V724000·2023-10-26

    Kia Recalls 2015-2019 Soul EV for Parking Mechanism Defect

    Kia is recalling 2015-2019 Soul EV vehicles because a damaged parking mechanism may cause unintended movement. Dealers will update software to fix the issue.

    Product
    KIA — KIA SOUL EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0060-2024·2023-10-25

    TPC Drops Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling TPC Drops ophthalmic solution due to lack of assurance of sterility. The recall affects 1693 droppers distributed nationwide.

    Product
    TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0062-2024·2023-10-25

    Lidocaine eye drops recalled due to lack of sterility assurance

    Pine Pharmaceuticals is recalling Lidocaine HCl 4% ophthalmic solution due to lack of sterility assurance. The affected product was distributed nationwide in 1,598 single-use droppers.

    Product
    Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2024·2023-10-25

    Endophth Kit Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals recalled an Endophth Kit (Vancomycin/Ceftazidime injectable) distributed nationwide due to lack of assurance of sterility. The recall affects 201 kits from lot 69986 (expires 11/15/2023).

    Product
    Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0063-2024·2023-10-25

    FDA Recalls Tropi-Phen Ophthalmic Solution Due to Sterility Assurance Failure

    Pine Pharmaceuticals has recalled 662 dropper units of Tropi-Phen ophthalmic solution due to lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2024·2023-10-25

    Doxil Chemotherapy Drug Recalled for Improper Storage Temperature During Shipment

    Baxter Healthcare is recalling 472 vials of Doxil chemotherapy medication due to exposure to temperatures exceeding labeled storage conditions during transportation. Affected vials were distributed nationwide.

    Product
    DOXIL — DOXIL (DOXORUBICIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2024·2023-10-25

    Surgical Instrument Shears Recalled Due to Incomplete Packaging Seal

    MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.

    Product
    MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0064-2024·2023-10-25

    Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance

    Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.

    Product
    Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide