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All product recalls affecting Pennsylvania.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Pennsylvania in the distribution area.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2017-2019 Beetle, Beetle Convertible, 2012-2014 Passat, 2017 Passat Wagon, and 2006-2007 Passat Sedan vehicles. The driver's side frontal air bag inflator may explode due to propellant degradation occurring after long-term exposure to high absolute humidity, high temperatures, and high temperature cycling.
Labeling: Missing Label
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Gillig, LLC (Gillig) is recalling certain 2024 Low Floor buses. A defective welded joint may cause the wiper arm to suddenly fail. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 104, "Windshield Wiping and Washing Systems."
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
Autocar, LLC (Autocar) is recalling certain 2022-2024 DC (Legend). The horizontal exhaust diffuser may be improperly positioned and vent exhaust toward the CNG fuel tank.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Chrysler (FCA US, LLC) is recalling certain Mopar Sophisticated Air Bag Sensor modules with part number 68332579AA. A software error in the air bag control module may cause the front air bags to deploy with excessive force during a crash. As such, this equipment fails to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
Failed Tablet/Capsule Specifications
Crystallization
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Ferrari North America, Inc (Ferrari) is recalling certain 2023 Portofino M, F8 Spider, and 2024 Roma Spider vehicles. The driveshaft screws may not have been tightened during production and may loosen.
Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.