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All product recalls affecting Louisiana.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Louisiana in the distribution area.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Volvo Bus Corporation (Volvo Bus) is recalling certain 2025 Volvo 9700 buses. The emergency exit labels that provide exit identification and operating instructions may not be secured properly, allowing the labels to detach. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
General Motors, LLC (GM) is recalling certain 2024 Chevrolet Silverado HD 2500, 3500, and GMC Sierra HD 2500, 3500 vehicles equipped with power-unlatching tailgates. The tailgate's electronic gate-release switch may short circuit due to water intrusion, which can result in the tailgate inadvertently unlatching while the vehicle is in Park.
Maserati North America, Inc. (Maserati) is recalling certain 2023-2024 Grecale and 2024 GranTurismo vehicles. The Central Vision Park Assist Module (CVPAM) software may prevent the rearview image from displaying when the vehicle is placed in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
Winnebago Industries, Inc. (Winnebago) is recalling certain 2024-2025 Ekko motorhomes. The wheel bolts for the spare tire may be missing
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Porsche Cars North America, Inc. (Porsche) is recalling certain 2024-2025 Macan Electric vehicles. The headlights may be too bright and exceed the maximum light output, which may adversely affect the vision of drivers. As such, these vehicles fail to comply with the requirements of the Federal Motor Vehicle Safety Standard (FMVSS) number 108, "Lamps, Reflective Devices, and Associated Equipment."
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Pagani S.p.A (Pagani) is recalling certain 2024 Utopia vehicles. The passenger side dashboard panel may have been manufactured incorrectly, which can cause the air bag not to deploy as intended.
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Braun Corporation (Braun) is recalling certain 2024 Chrysler Pacifica and Voyager vehicles. The seat limiter may not have been installed, allowing the seat to move too far forward. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Failed Impurities/Degradation Specifications