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.

6951–6975 of 52962

  • HighFDA (Devices)·Z-0039-2025·2024-10-16

    GE Healthcare Centricity Universal Viewer may fail to display latest diagnostic report

    GE Healthcare Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x may fail to show the latest diagnostic report by default when a study contains multiple DICOM structured reports in different series.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0055-2025·2024-10-16

    Enterprise Imaging XERO Viewer medical software reference line placement error

    Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.

    Product
    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2025·2024-10-16

    Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs

    The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.

    Product
    Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2025·2024-10-16

    Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels

    Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.

    Product
    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2025·2024-10-16

    Tonsil tray kits recalled for containing component under improper use recall

    Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.

    Product
    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2025·2024-10-16

    3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination

    3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.

    Product
    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0043-2025·2024-10-16

    Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results

    The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.

    Product
    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2025·2024-10-16

    Endoscopy and Bronchoscopy Systems Power Cord Defect Risk

    Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.

    Product
    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V764000·2024-10-15

    2018–2022 BMW X3 rear cargo rail attachment defect recall

    BMW is recalling 2018–2022 X3 vehicles because rear cargo rail attachment bolts may become damaged in a rear crash, causing the rail to detach and increasing injury risk. Dealers will replace the bolts free of charge.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V767000·2024-10-15

    2024 Toyota Sequoia Hybrid and Tundra Tire Sidewall Damage Recall

    Certain 2024 Toyota Sequoia Hybrid, Tundra, and Tundra Hybrid vehicles are recalled due to passenger-side front and rear tire sidewall damage that may cause sudden tire pressure loss and loss of vehicle control.

    Product
    TOYOTA — TOYOTA TUNDRA, TUNDRA HYBRID, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V765000·2024-10-15

    Lamborghini Recalls 2024 Revuelto Vehicles Due to Wiper Rod Defect

    Lamborghini is recalling 2024 Revuelto vehicles because a wiper connecting rod may bend and separate, causing wiper failure and reduced visibility.

    Product
    LAMBORGHINI — LAMBORGHINI REVUELTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V762000·2024-10-14

    Entegra Ethos and Jayco Swift Incorrect Tire Load Label Recall

    Jayco is recalling 2,044 units of 2021–2025 Entegra Ethos and Jayco Swift vehicles due to an incorrect Tire and Loading Information Label. The mislabeled tire load range could lead owners to select underrated replacement tires, increasing crash risk.

    Product
    JAYCO — JAYCO, ENTEGRA SWIFT LI, SWIFT, ETHOS LI, ETHOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V763000·2024-10-14

    2025 Honda Civic fuel pump defect poses fire risk

    Honda is recalling certain 2023-2025 model year Civic vehicles because the high-pressure fuel pump may crack and leak fuel, increasing the risk of fire if an ignition source is present. Owners should contact Honda for free inspection and replacement.

    Product
    HONDA — HONDA ACCORD, CIVIC, CIVIC HYBRID, CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V758000·2024-10-11

    Blue Bird Recalls School Buses for Illegible Emergency Exit Labels

    Blue Bird is recalling 2019-2024 Vision and All American school buses because emergency exit labels are too small to read, potentially delaying evacuation.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V760000·2024-10-11

    E-One Recalls Fire Trucks Due to Engine Crossmember Defect

    E-One is recalling 282 fire trucks because a broken engine crossmember can damage the cooling fan, causing an engine stall and increasing crash risk.

    Product
    E-ONE — E-ONE TYPHOON N, CYCLONE N, QUEST II, CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V759000·2024-10-11

    Blue Bird Transit Bus Recall for Illegible Emergency Exit Labels

    Blue Bird is recalling 2020-2024 All American and 2021-2024 Vision transit buses because emergency exit labels are too small to read, potentially delaying evacuation.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V761000·2024-10-11

    Hyundai Nexo Hydrogen Pressure Relief Device Defect Creates Fire Risk

    Hyundai is recalling 2019-2024 Nexo vehicles because the hydrogen pressure relief device may fail and leak, creating a fire risk. Owners are advised to park outside until the repair is complete.

    Product
    HYUNDAI — HYUNDAI NEXO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V757000·2024-10-10

    2024-2025 Kia EV9 Instrument Panel Display Software Error Recall

    Kia is recalling 2024-2025 EV9 vehicles due to a software error affecting the instrument panel display. The display may fail to show critical safety information such as the speedometer and warning lights.

    Product
    KIA — KIA EV9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V755000·2024-10-10

    2024 GMC Sierra EV front turn signals may be difficult to see

    General Motors is recalling certain 2024 GMC Sierra EV vehicles. The front turn signal lights are too similar in brightness to the parking lights, making them difficult to see and increasing crash risk.

    Product
    GMC — GMC SIERRA EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E083000·2024-10-10

    Chrysler Recalls MOPAR Trailer Tow Mirrors Due to Detaching Glass

    Chrysler is recalling specific MOPAR trailer tow mirrors because the glass may detach, reducing driver visibility and increasing crash risk.

    Product
    VISIBILITY:REARVIEW MIRRORS/DEVICES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V754000·2024-10-10

    2020-2023 RAM 1500 Heated Rearview Mirror Glass May Detach

    Chrysler is recalling 2020-2023 RAM 1500 vehicles with heated trailer tow rearview mirrors. The mirror glass may detach, reducing driver visibility and increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25008·2024-10-10

    Gimars Playpens Recalled for Head Entrapment and Suffocation Hazards

    About 6,200 Gimars Playpens with Mat are recalled because the basketball hoop accessory poses a head entrapment hazard and children can become entrapped beneath the mattress, creating a suffocation risk. The products violate federal play-yard safety regulations.

    Product
    Gimars Playpen with Mat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25007·2024-10-10

    Droyd Multi-Purpose Helmets Recalled for Head Injury Risk

    Reyhee Group is recalling about 400 Droyd multi-purpose helmets sold online from October 2023 through July 2024. The helmets do not meet federal safety requirements and can fail to protect wearers in a crash.

    Product
    Droyd multi-purpose helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide