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All product recalls affecting Maryland.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maryland in the distribution area.
VinFast Auto, LLC (VinFast) is recalling certain 2022-2024 VF8 vehicles. Inactive ignitors may have been installed in the air bags.
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2023 AMG C43 4MATIC vehicles, equipped with AMG Performance seats. The seat wiring harness may be incorrectly routed, which can cause it to become damaged when the seat is fully reclined.
CGMP Deviations
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
This recall involves TOPINCN 1.5-inch and 3-inch round pool drain covers sold for use in swimming pools. The drains have two screws and measure about 4 inches (outer diameter) by 2 inches (inner diameter) for the 1.5-inch drain cover. The 3-inch drain cover measures about 5 inches (outer diameter) by 3 inches (inner diameter). They are white and made of plastic.
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
Rivian Automotive, LLC. (Rivian) is recalling certain 2023-2024 EDV, R1S, and R1T vehicles. The headlights may be improperly aimed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamp, Reflective Devices and Associated Equipment."
General Motors, LLC (GM) is recalling certain 2024 Chevrolet Colorado vehicles. Incorrect tires may have been installed that do not match the tire label, and the tire pressure monitoring system (TPMS) may provide inaccurate information for the installed tires. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 110, "Tire Selection and Rims" and 138, "Tire Pressure Monitoring Systems."
Nexxpro-Fabrica de Capacetes, S.A. (Nexxpro) is recalling certain NEXX X.G10 helmets, sizes M and S. The helmets may have been manufactured without an extra carbon layer and may not provide adequate protection in the event of a head impact during a crash. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 218, "Motorcycle Helmets."
Jaguar Land Rover North America, LLC (Land Rover) is recalling certain 2018-2022 Range Rover Sport vehicles equipped with a Surround Camera System. Water may enter into the rearview camera, which can cause the rearview camera image not to appear on the display or display a distorted image. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."
Blue Bird Body Company (Blue Bird) is recalling certain 2021-2023 Vision school buses. The diesel tank that supplies the fuel fired heater was improperly designed and may leak fuel. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 301, "Fuel System Integrity."
Kovatch Mobile Equipment Corp. (KME) is recalling certain 2022-2023 Predator fire trucks. The incorrect relay valve may have been installed, which can prevent the park brake from engaging and allow the vehicle to roll away. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 121, "Air Brake Systems."
Altec Industries, Inc. (Altec) is recalling certain 2020-2024 Altec LR7 and LR8 aerial devices. The hydraulic cylinder feeder tube routed near the cylinder rest bracket may become damaged and leak oil, which can result in uncontrolled boom movement.
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Lack of Assurance of Sterility: Leaking vials
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.