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All product recalls affecting Louisiana.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Louisiana in the distribution area.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Discoloration; discolored solution from cracked vials
Lack of Assurance of Sterility
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Ultrasound transducer devices were refurbished beyond their useful life.
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Ultrasound transducer devices were refurbished beyond their useful life.
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Sailun Tire Americas, Inc. (Sailun) is recalling certain Transamerican New Mutant X-AT Predator tires, size 265/70R17 115S. The sidewall may have a puncture and leak air. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 139, "New Pneumatic Radial Tires for Light Vehicles."
Kia America, Inc. (Kia) is recalling certain 2025 K5 vehicles. A software error in the Power-net Domain Controller (PDC) may cause the parking lights to flicker. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) 108, "Lamps, Reflective Devices, and Associated Equipment."
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lack of Assurance of Sterility
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Micro DOT Helmet Co. (Micro DOT) is recalling certain Blister and Twister original helmets, sizes XXS - XXL. The helmets may lack proper penetration protection. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 218, "Motorcycle Helmets."
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.