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All product recalls affecting Maryland.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maryland in the distribution area.
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.
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Grand Design RV, LLC (Grand Design) is recalling certain 2024-2025 Momentum 320G, 325G, 344M, 250G, 351MS, 381MS, 392M, 395MS, 397THS, 398M, 399TH, 410TH, 414M, and 415G toy haulers, equipped with a removable step assembly. The clip-on bracket mounting bolts may come loose, allowing the steps to detach.
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Porsche Cars North America, Inc. (Porsche) is recalling certain 2022-2023 Taycan vehicles. An occupant classification system error may deactivate the front passenger air bag.