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All product recalls affecting South Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with South Dakota in the distribution area.
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Motiv Power Systems, Inc. (Motiv) is recalling certain 2021-2024 E-450, 2019-2023 F-59, and 2019-2020 F-53 vehicles equipped with a Motiv Gen 5 EPIC powertrain. The vehicle control software could misclassify a loss of isolation between the chassis and high voltage system, shutting down the high voltage (HV) batteries.
A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.
Motiv Power Systems, Inc. (Motiv) is recalling certain 2021-2024 E-450 vehicles equipped with a Motiv Gen 5 EPIC powertrain. The Controller Area Network (CAN) signal wires could contact the frame rail and become damaged, causing a loss of drive power.
CGMP Deviations
Blue Bird Bus Company (Blue Bird) is recalling certain 2019-2023 Vision, All American Front Engine, and All American Rear Engine school buses. An exterior roof joint may have been manufactured with insufficient strength that can allow the roof panels to separate in a crash. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 221, "School Bus Body Joint Strength."
Doosan North America, Inc. (Doosan) is recalling certain 2024 Bobcat PG25 portable generator trailers. The wheel lug nuts may be improperly tightened.
Ford Motor Company (Ford) is recalling certain 2023-2024 Transit vehicles equipped with a Transit Trail package. The electronic power assist steering (EPAS) ground eyelet joint may experience corrosion, which can result in a loss of power steering assist.
Ford Motor Company (Ford) is recalling certain tie rod assemblies, with part numbers FC4Z-3280-FA and FC4Z-3280-HA. The front axle tie rod assemblies may contain ball studs that have been incorrectly heat-treated, which can cause them to break, and possibly result in tie rod failure.
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
Maserati North America, Inc. (Maserati) is recalling certain 2022-2024 Maserati MC20, and 2023-2024 MC20 Cielo vehicles. The Vehicle Capacity Weight (VCW) on the tire label may state incorrect information. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 110, "Tire Selection and Rims."
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Chrysler (FCA US, LLC) is recalling certain 2019-2021 Pacifica Plug-In Hybrid Electric (PHEV) vehicles. The battery pack may cause a vehicle fire when parked, even with the ignition in the "Off" position.
Honda (American Honda Motor Co.) is recalling certain 2024 Prologue vehicles. The right front lower control arm may contain a manufacturing defect that can cause it to fracture.
Uncertainty in the seal integrity of the sterile packaging.
Uncertainty in the seal integrity of the sterile packaging.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.