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Non-Sterility
CGMP Deviations
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Proterra Operating Company, Inc. (Proterra) is recalling certain 2020-2022 35" Catalyst, 35" ZX5, and 40" ZX5 vehicles. The windshield wiper motors may operate intermittently or may fail to operate. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 104, "Windshield Wiping and Washing Systems."
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Lakota Corporation (Lakota) is recalling certain 2019-2023 Bighorn trailers. The trey ceiling above the bed may not have been installed correctly and may detach.
Subaru of America, Inc. (Subaru) is recalling certain 2004-2005 Impreza and WRX vehicles that received replacement front passenger air bag inflators under a previous recall. The replacement air bag inflators may have been installed incorrectly.
Braun Corporation (Braun) is recalling certain child seat weldments sold as accessory parts to the BraunAbility Turny Seat, model number 225 and part number TAS-01223. The child restraint lower anchors may have been manufactured with improper welds.
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Daimler Trucks North America, LLC (DTNA) is recalling certain 2017-2023 Freightliner Cascadia, 2020-2023 Western Star 49X, 2021-2023 Western Star 47X, and 2022 Freightliner 114SD vehicles. The brake modulator valves on the front axle may corrode and cause the vehicle to pull to the affected side during braking initiated by Electronic Stability Control (ESC) or Roll Stability Control (RSC).
Ford Motor Company (Ford) is recalling certain 2020-2022 Explorer vehicles equipped with a 2.3L engine and 10R60 automatic transmission. An unintentional powertrain control module (PCM) reset may occur while the vehicle is in motion and result in park system damage.
Thor Motor Coach (TMC) is recalling certain 2021-2023 Rize and Scope camper vans. The retractable awning may extend unintentionally during transit.
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Navistar, Inc. (Navistar) is recalling certain 2022-2024 IC Bus CE, 2022-2023 IC CE SBus, IC RE, and 2023 EV school buses. The roof panel may have been manufactured with insufficient joint strength. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 221, "School Bus Body Joint Strength."
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2022 EQS580 vehicles. The multi-purpose camera and the rearview mirror may be insufficiently attached to the windshield and may detach, impairing front passenger air bag deployment and various assistance systems, including Adaptive Cruise Control (DISTRONIC) with active steering assist, Brake Assists with pedestrian detection, Lane Keeping Assists, Traffic Sign Assist, Augmented Reality function and Rain and Light Sensors.