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.

9776–9800 of 22145

  • HighFDA (Devices)·Z-0022-2025·2024-10-16

    FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode

    Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.

    Product
    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0033-2025·2024-10-16

    Medline Blood Pressure Monitor Recalled for Microchip Failure and Overheating

    Medline is recalling approximately 9,608 automatic digital blood pressure units due to a faulty microchip that causes power failures, display issues, and overheating.

    Product
    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0053-2025·2024-10-16

    Medline Sterile Laparoscopy Pack Recalled for Component Defect

    Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.

    Product
    Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
    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-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-0050-2025·2024-10-16

    StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

    Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

    Product
    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2025·2024-10-16

    Monarch Platform Urology Device Recalled for Power Cord Electrical Hazard

    Auris Health is recalling Monarch Platform (Urology) devices due to strain relief defects in power cords that may cause electrical short and potential shock to operating room staff.

    Product
    Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V916000·2024-10-12

    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 — 2025 GRAND DESIGN MOMENTUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V830000·2024-10-12

    2023 Kia Soul Side Curtain Airbags May Deploy Unexpectedly

    Kia is recalling 2023 Soul and 2024 Seltos vehicles because side curtain airbags may deploy unexpectedly due to a manufacturing error, increasing the risk of injury or crash. Dealers will replace affected modules free of charge.

    Product
    KIA — 2023 KIA SOUL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V889000·2024-10-12

    Prevost Bus Wheelchair Lift Warning Beacon May Be Insufficiently Bright

    Prevost is recalling certain H3-41, H3-45, X3-45, and X3-45 Commuter vehicles from 2012–2024. The red warning beacon on the wheelchair lift may not be bright enough, potentially making the lift less visible to users.

    Product
    PREVOST — 2013 PREVOST H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V918000·2024-10-12

    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 — 2022 JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V885000·2024-10-12

    2024 BMW i5 Electric Vehicles Pedestrian Warning Sound System May Fail

    BMW is recalling 2024 i5 electric vehicles where the external pedestrian warning sound generator may fail during startup. This could leave pedestrians unaware of approaching vehicles, increasing injury risk.

    Product
    BMW — 2024 BMW I5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V790000·2024-10-11

    2024 Land Rover Range Rover oil cooler hose recall

    Certain 2024 Land Rover Range Rovers may have improperly secured engine oil cooler hoses that could leak oil onto roadways, creating a hazard for other drivers and increasing crash risk.

    Product
    LAND ROVER — 2024 LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V792000·2024-10-11

    Mack Trucks Recalled for Accelerator Control System Sensor Failure

    Mack is recalling 650 2023–2024 trucks due to a sensor defect that can prevent the engine from returning to idle quickly, risking loss of vehicle control. The company will replace the throttle pedal and update software at no cost.

    Product
    MACK — 2023 MACK ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V785000·2024-10-11

    Cadillac Lyriq seat belt bracket defect recall for 2023-2024 models

    General Motors is recalling certain 2023-2024 Cadillac Lyriq vehicles because the bracket anchoring the rear seat belts may have been improperly welded. The defect may prevent the seat belts from properly restraining occupants during a crash.

    Product
    CADILLAC — 2024 CADILLAC LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V791000·2024-10-11

    2021 Nissan Rogue rear brake calipers may leak fluid

    Certain 2021 Nissan Rogue vehicles may have missing internal bushings in rear brake calipers, allowing brake fluid to leak and reduce braking performance.

    Product
    NISSAN — 2021 NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V788000·2024-10-11

    Grand Design Reflection Travel Trailers Recalled Due to Electrical Fire Hazard

    Grand Design is recalling 2024 Reflection travel trailers with reversed electrical receptacles that can fail and increase fire risk. Owners should contact dealers for free replacement.

    Product
    GRAND DESIGN — 2024 GRAND DESIGN REFLECTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V793000·2024-10-11

    2023-2024 Volvo VN Trucks Recalled for Accelerator Control System Defect

    Volvo Trucks is recalling certain 2023-2024 VN trucks because the accelerator pedal position sensor may disconnect, preventing the engine from returning to idle quickly. This can cause loss of vehicle control and increase crash risk.

    Product
    VOLVO — 2023 VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V787000·2024-10-11

    2021-2023 Jeep Wrangler plug-in hybrid battery fire hazard

    Chrysler is recalling certain 2021-2023 Jeep Wrangler plug-in hybrid vehicles due to high-voltage battery failures that may cause vehicle fires. Owners are advised not to recharge vehicles and to park outside away from structures until repairs are completed.

    Product
    JEEP — 2022 JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25010·2024-10-10

    NPW Group Recalls Halloween Projector Flashlights Due to Fire and Burn Hazards

    NPW Group is recalling about 4,700 Halloween Projector Flashlights sold at Target in September 2024 because they can overheat, melt, and cause fire and burn injuries. Consumers should stop using them immediately and return them to Target for a refund.

    Product
    Halloween Projector Flashlights
    Category
    Consumer Product
    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