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Lack of Assurance of Sterility
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2021 S580 4Matic vehicles. The air bag control unit may be improperly secured and may result in an unintentional air bag or seat belt deployment, or an improper deployment in the event of a crash.
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2020 AMG CLA 35 and 2021 GLA 250 vehicles. The rear brake caliper housing fasteners may be loose, which can reduce brake performance or cause rear brake components to detach from the vehicle.
Kia Motors America (Kia) is recalling certain 2022 Sorento Hybrid and Sorento Plug-in Hybrid vehicles. In the event of a crash, the front driver-side and/or passenger-side seat belt pretensioner(s) may explode upon deployment.
There is a potential for misquantitation high results for negative samples.
Hino Motors Sales U.S.A., Inc. (Hino) is recalling certain 2022 NJ7A vehicles. The charge pipe flare nut attached to the air compressor may not have been tightened properly, resulting in low air pressure in the system.
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Software issue resulting in temporary loss of central monitoring functionality.
There is a potential for misquantitation high results of negative samples.
Midwest Automotive Designs, LLC (Midwest) is recalling certain 2018-2020 Passage, Weekender, and Daycruiser Sprinter Vans equipped with a Multiplex G9 unit used for controlling equipment and accessories in the motorhome. Excessive voltage may cause the components on the board to become damaged.
This recall involves Ski-Doo 2020, 2021 and 2022 Expedition LE, SE and SWT snowmobiles with a 900 ACE turbo engine. The vehicles were sold in a variety of colors. Ski-Doo and the model name are printed on the side panels of the vehicles. The vehicle identification number (VIN) is on the decal located on the right-hand side of tunnel underneath the seat. The following models are included in the recall: Model Year Model Name 2020 Ski-Doo Expedition SE 900 ACE Turbo 2020 Ski-Doo Expedition LE 900 ACE Turbo 2021 Ski-Doo Expedition SE 900 ACE Turbo 2021 Ski-Doo Expedition LE 900 ACE Turbo 2021 Ski-Doo Expedition SWT 900 ACE Turbo 2022 Ski-Doo Expedition SE 900 ACE Turbo 2022 Ski-Doo Expedition LE 900 ACE Turbo 2022 Ski-Doo Expedition SWT 900 ACE Turbo
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Jayco, Inc. (Jayco) is recalling certain 2019-2022 Seneca, Seneca Prestige, Entegra Accolade and Accolade XL motorhomes. The tire valve stem extension for the inner wheel may come into contact with the outer wheel rim opening and become damaged.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results