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potential Listeria Monocytogenes Contamination
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Peragon Enterprises, Inc. (Peragon) is recalling certain Peragon Tectonic hard, three-panel tonneau covers. The bed cover's plastic slides may become damaged and allow the cover to detach during transit.
Polestar Automotive USA, Inc. (Polestar) is recalling certain 2025 Polestar 3 vehicles. The panoramic glass sunroof may not be properly secured and can detach.
American Manufacturing Operations, Inc. (AMO) 2025 AMO Utility trailers. The shackle nuts securing the axle to the chassis may loosen, allowing the axle to detach from the trailer.
Temperature abuse due to temperature excursion in one shipping trailer