The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

3626–3650 of 29102

  • SevereFDA (Drugs)·D-0300-2024·2024-02-14

    Target Lubricant Eye Drops Recalled for Non-Sterility

    Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 bottles.

    Product
    Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2024·2024-02-14

    Gamma Camera Detector May Fall Due to Component Failure

    The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.

    Product
    BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2024·2024-02-14

    Eye Irritation Relief Drops Recalled Nationwide for Non-Sterility

    Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2024·2024-02-14

    Up&Up Dry Eye Relief Nationwide Recall for Non-Sterility

    Up&Up brand dry eye relief (0.5 FL OZ) distributed by Target nationwide is being recalled due to non-sterility. The FDA Class I recall affects all lots of this ophthalmic drug.

    Product
    Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0849-2024·2024-02-14

    Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues

    Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.

    Product
    Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0858-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change

    Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.

    Product
    Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0858-2024·2024-02-14

    Sandwich Recalled for Undeclared Egg in Authentic Fresh Club

    MG Foods Middletown is recalling approximately 852 units of Authentic Fresh to You Deluxe Triple Decker Club sandwiches (8.8oz) because they contain undeclared egg. The products were distributed to PA, NJ, MD, and NY.

    Product
    Authentic Fresh to You Deluxe Triple Decker Club Net Wt. 8.8oz (254g). Product packaged in a plastic PET container.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0851-2024·2024-02-14

    Cardinal Health Monoject Syringes and Enteral Syringes Removed

    Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V107000·2024-02-13

    Hyundai Recalls Genesis Models Due to Starter Solenoid Fire Risk

    Hyundai is recalling certain 2015-2019 Genesis vehicles because water in the starter solenoid can cause an electrical short and engine fire.

    Product
    HYUNDAI — HYUNDAI, GENESIS GENESIS, G80, G90, G70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E010000·2024-02-09

    R.H. Sheppard Recalls Steering Gears Due to Fracture Risk

    R.H. Sheppard is recalling steering gears where the sector shaft may have been improperly heat-treated, potentially causing cracks or fractures that lead to loss of steering control.

    Product
    STEERING:GEAR BOX:SHAFT SECTOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V101000·2024-02-09

    Foretravel Recalls 2023 Realm Vehicles Due to Steering Gear Defect

    Foretravel is recalling 2023 Realm and Realm Presidential vehicles because foreign material in the steering gear may cause a loss of power steering assist, increasing crash risk.

    Product
    FORETRAVEL — FORETRAVEL REALM PRESIDENTIAL, REALM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V097000·2024-02-09

    2021-2022 Ford E-350 and E-450 Power Steering Fluid Loss Recall

    Ford is recalling certain 2021-2022 E-350 and E-450 vehicles due to a defective power steering connection that may cause loss of power steering fluid and brake assist.

    Product
    FORD — FORD E-350, E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V098000·2024-02-09

    Vermeer Recalls BC1800XL Trailers Due to Tongue Weldment Crack Risk

    Vermeer is recalling 2016-2024 BC1800XL brush chipper trailers because the tongue weldment may crack and separate from the tow hitch, increasing crash risk.

    Product
    VERMEER — VERMEER BC1800XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V092000·2024-02-08

    Vicinity Recalls 2022 Vi35 Buses Due to CNG Tank Clearance Issue

    Vicinity is recalling 2022 Vi35 transit buses because inadequate clearance may damage CNG tanks, increasing the risk of natural gas leaks and fire.

    Product
    VICINITY — VICINITY VI35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V089000·2024-02-08

    Navistar Recalls 2024 IC Bus CE School Buses for Steering Defect

    Navistar is recalling 2024 IC Bus CE school buses because steering gear assemblies may have fewer recirculating balls than required, risking loss of steering control.

    Product
    IC BUS — IC BUS CE SBUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V088000·2024-02-08

    2024 International Trucks Steering Defect May Cause Loss of Control

    Navistar recalls 2024-2025 International trucks and 2024 IC Bus commercial buses due to steering gear assemblies that may be incorrectly assembled, potentially causing loss of steering control.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS LT, MV, HV, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V084000·2024-02-08

    Western Star 49X Suspension Hanger Defect May Affect Steering Control

    Daimler Trucks North America is recalling 2022-2024 Western Star 49X vehicles with suspension hangers that may fail due to missing welds, potentially impairing steering and directional control.

    Product
    WESTERN STAR — WESTERN STAR 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24113·2024-02-08

    Husqvarna Gas-Powered Grass Trimmers Recalled for Fire Hazard

    Husqvarna is recalling about 403,000 gas-powered grass trimmers due to incorrect wiring in the ignition module that can cause electrical sparks or arcing, creating a fire hazard. The firm has received 12 reports of fires, including one burn injury.

    Product
    Gas-powered Grass Trimmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide