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All product recalls affecting Kentucky.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Kentucky in the distribution area.
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Failed Dissolution Specifications
Undeclared walnuts
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
PACCAR Incorporated (PACCAR) is recalling certain 2024 Peterbilt 367, 389, 548, Kenworth T480, T800, 2024-2025 Peterbilt 520, 567 and Kenworth T880 vehicles with PACCAR 20k steer axles. The steering arm and/or tie rod bracket fasteners may fail, resulting in a loss of steering control.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Nova Bus (US) Inc. (Nova Bus) is recalling certain 2022-2024 LFS buses. The wheelchair securement system may have been installed with the attachment points in the incorrect locations.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Reports of various packaging issues that may result in a breach of the sterile barrier.
International Motors, LLC (International) is recalling certain 2025 EMV vehicles. A circuit breaker may be missing, causing the defrosting system to be inoperative. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 103, "Windshield Defrosting and Defogging Systems."
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Tesla, Inc. (Tesla) is recalling certain 2024 Model X vehicles. The parking lights and low beam headlights may flicker. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 108, "Lamps, Reflective Devices, and Associated Equipment."
PACCAR Incorporated (PACCAR) is recalling certain 2024 Peterbilt 537, 2024-2025 Kenworth T380, T480, Peterbilt 548, and 2025 Peterbilt 536 trucks, equipped with certain Meritor 10-16K and 18-23K front steer drive axles. The front steer drive axles may have insufficient wheel bearing lubricant.
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Pierce Manufacturing (Pierce) is recalling certain 2023-2024 Enforcer, Quantum, and Velocity fire trucks. The tires mounted on the front steer axles are incompatible with the wheels. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 120, "Wheels and Rims - Other Than Passenger Cars."
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.