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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
Unreleased software versions were installed on distributed devices without verification or validation.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Polestar Automotive USA, Inc. (Polestar) is recalling certain Polestar 3 vehicles. The rearview camera image may not display when the vehicle is placed in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."
Unreleased software versions were installed on distributed devices without verification or validation.
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Unreleased software versions were installed on distributed devices without verification or validation.
Shyft Group (Shyft) is recalling certain 2025 Utilimaster Aeromaster vehicles. The rear seat belts may not have been installed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
Unreleased software versions were installed on distributed devices without verification or validation.
Failed Impurities/Degradation Specifications
Volkswagen Group of America, Inc. (Audi) is recalling certain 2022-2024 Q5 Quattro and Q5 Sportback Quattro vehicles. The cylinder head cover screws may have been improperly tightened.
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Blue Bird Body Company (Blue Bird) is recalling certain 2026 Vision and All American school buses equipped with a lap belt-ready or 3-pt seats. The seat mounting fasteners may have been improperly tightened. As such, these vehicles fail to comply with Federal Motor Vehicle Safety Standard numbers 207, "Seating Systems," 210, "Seat Belt Assembly Anchorages," and 222, "School Bus Passenger Seating and Crash Protection."
Hyundai Motor America (Hyundai) is recalling certain 2025 Hyundai Palisade vehicles. An insufficient seal on the controller for the electric oil pump may allow moisture to accumulate in the printed circuit board, which can cause an electrical short and result in a fire.
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
K.Z., Inc. (KZRV) is recalling certain 2025 Durango Gold fifth wheels, equipped with a removable step assembly. The clip-on bracket mounting bolts may come loose, allowing the steps to detach.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.