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All product recalls affecting Puerto Rico.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Puerto Rico in the distribution area.
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.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Apollo Tires (US) Inc. (Apollo Tires) is recalling certain Vredestein Hitrac, Quatrac, and Quatrac Pro+ tires. A contaminated compound may cause the steel belts to separate.
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
ST Engineering Hackney, Inc. (STE Hackney) is recalling certain 2023-2024 Kidron Refrigerated Trailers. The wheel lug nuts may not be tightened properly.
Diamond Coach Corporation (Diamond Coach) is recalling certain 2023-2024 VIP 2200 transit buses, equipped with certain GO-ES Space Saver Foldaway Seats. The recliner mechanism may not engage when the seat back is fully reclined. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Volkswagen Group of America, Inc. (Audi) is recalling certain 2022-2024 Q4 E-TRON and Q4 E-TRON Sportback vehicles. The incorrect headlight control module software may have been installed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."