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.

5201–5225 of 29102

  • SevereFDA (Devices)·Z-1275-2023·2023-04-12

    FreeStyle Libre Reader batteries pose fire and swelling hazard

    FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.

    Product
    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0697-2023·2023-04-12

    Clio Strawberry Granola & Yogurt Parfait Bars Recalled Due to Listeria Risk

    Clio Strawberry Granola & Yogurt Parfait Bars (UPC 854021008152) are being recalled due to possible Listeria contamination. Affected products were distributed to retail stores in Iowa, Illinois, Virginia, Wisconsin, and North Carolina.

    Product
    Clio Strawberry Granola & Yogurt Parfait Bar Net Wt. 1.94 OZ (55g ) UPC: 854021008152 Packaged in a cardboard box.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1322-2023·2023-04-12

    Philips DreamStation respiratory devices recalled for communication issues affecting prescription settings

    Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.

    Product
    Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0732-2023·2023-04-12

    Gerber GoodStart SoothePro infant formula recalled due to possible Cronobacter contamination

    Perrigo Nutritionals is recalling Gerber GoodStart SoothePro infant formula due to potential Cronobacter contamination. The recall affects 182,888 cans distributed nationwide and in Canada.

    Product
    Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb /
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1288-2023·2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1273-2023·2023-04-12

    FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard

    FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.

    Product
    FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2023·2023-04-12

    FreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard

    Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.

    Product
    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E031000·2023-04-11

    Meritor Recalls Front Drive Steer Axles Due to Fastener Loosening

    Meritor is recalling specific front drive steer axles because fasteners may loosen, potentially causing axle separation and loss of vehicle control.

    Product
    STEERING:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V255000·2023-04-07

    Volvo VNR Trucks Recalled for Aggressive Adaptive Cruise Control Braking

    Volvo Trucks is recalling 2020-2023 VNR Electric vehicles equipped with Adaptive Cruise Control that can trigger aggressive braking under light load conditions, risking rear axle skidding and loss of vehicle control.

    Product
    VOLVO — VOLVO VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V207000·2023-04-07

    Lightning eMotors Recalls 148 Vehicles Due to Battery Pack Defects

    Lightning eMotors is recalling 148 electric vehicles because defective battery pack welds may cause internal leaks, leading to battery failure, loss of power, or fire.

    Product
    LIGHTNING EMOTORS — LIGHTNING EMOTORS FT3-86, FE4-129, FT3-43, FE4-86
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V259000·2023-04-07

    Thomas Built Buses Recall 48 School Buses for Steering Defect

    Daimler Trucks North America is recalling 48 Thomas Built Buses school buses because a missing fastener may allow the steer arm to detach, risking loss of steering control.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2 JOULEY, SAF-T-LINER C2, SAF-T-LINER MVP-EF, HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V257000·2023-04-07

    Buell Recalls 2021-2022 1190 RX and SX Motorcycles for Gear Shift Defect

    Buell Motorcycles is recalling 2021-2022 1190 RX and SX motorcycles because an improperly installed index spring may cause gear slipping or shifting failure, increasing crash risk.

    Product
    BUELL — BUELL 1190 SX, 1190 RX HAMMERHEAD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V253000·2023-04-06

    2023 BMW X5 Head Restraints May Fail in Crash

    BMW is recalling approximately 235 certain 2023 X5 vehicles with defective second-row head restraints that may not properly restrain occupants during a crash, violating federal safety standards.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23174·2023-04-06

    Mammut Avalanche Shovels Recalled for Spring Locking Mechanism Failure

    Mammut Sports Group is recalling Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels because the spring locking mechanism can fail during emergency excavation, posing risk of injury or death.

    Product
    Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V245000·2023-04-06

    Prevost Recalls 2023 X3-45 Motor Coaches Due to Electrical Fire Risk

    Prevost is recalling 2023 X3-45 and X3-45 VIP motor coaches because an insufficient grommet allows electrical cables to chafe, potentially causing a short circuit and fire.

    Product
    PREVOST — PREVOST X3-45 VIP, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V246000·2023-04-06

    Prevost Recalls 2023 X3-45 VIP Motor Coaches Due to Fire Risk

    Prevost is recalling 2023 X3-45 VIP motor coaches because a missing grommet allows electrical cables to chafe, potentially causing a short circuit and fire.

    Product
    PREVOST — PREVOST X3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0651-2023·2023-04-05

    Enoki Mushrooms Recalled Due to Listeria monocytogenes Contamination

    SSS brand and K-Fresh branded enoki mushrooms are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    SSS brand and K-Fresh branded Enoki Mushrooms Packaged in clear plastic 200g container
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V243000·2023-04-05

    New Flyer Recalls 2023 XD60 and XDE60 Buses for ABS Failure

    New Flyer is recalling 2023 XD60 and XDE60 buses because the anti-lock brake system may lose power during hard braking, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XDE60, XD60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0686-2023·2023-04-05

    ISH Shrimpish Sample Meal Kit Recalled for Undeclared Soy Protein

    THE ISH COMPANY is recalling 355 ISH Shrimpish Sample Meal Kits distributed to multiple states throughout 2022 for undeclared soy protein that may cause allergic reactions in sensitive consumers.

    Product
    ISH Shrimpish Sample Meal Kit: ( Sample Meal Kit ) a package containing two ISH Foods plant-based Shrimpish products and several additional meal components. Each kit is shipped frozen, using styrofoam and dry ice. Affected components: ¿ Broth Plastic jar with lid ¿ XO Sauce
    Category
    Food
    Distribution
    36 states
  • SevereNHTSA·23V242000·2023-04-05

    Maserati Recalls 2023 MC20 Cielo for Windshield Frame Bonding Defect

    Maserati is recalling 2023 MC20 Cielo vehicles because insufficient windshield frame bonding could allow the frame to detach in a crash, increasing injury risk.

    Product
    MASERATI — MASERATI MC20 CIELO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E029000·2023-04-03

    Cruise Recalls Autonomous Driving Software Due to Crash Risk

    Cruise LLC is recalling certain Automated Driving Systems with specific software versions that may inaccurately predict the movement of articulated vehicles, increasing the risk of a crash.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V235000·2023-03-31

    Tesla Recalls 2018-2019 Model 3 Vehicles for Suspension Fastener Issue

    Tesla is recalling 2018-2019 Model 3 vehicles because front suspension fasteners may loosen, potentially causing the lateral link to separate and increasing crash risk.

    Product
    TESLA — TESLA MODEL 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V227000·2023-03-31

    Forest River Recalls 2023 East to West Travel Trailers Due to Drawbar Defect

    Forest River is recalling 2023 East to West Della Terra and Silver Lake travel trailers because the drawbar assembly may break, potentially allowing the trailer to detach.

    Product
    EAST TO WEST — EAST TO WEST DELLA TERRA, SILVER LAKE
    Category
    Vehicle
    Distribution
    Distributed nationwide