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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
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."
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
Turtle Top is recalling certain 2024 Van Terra, Terra Transit, Odyssey, and Odyssey XL vehicles, 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."
Cummins, Inc. (Cummins) is recalling certain Cummins L9 diesel engines with part number D563027BX03. The remote fuel filter hoses may become separated from the fitting, which can result in a fuel leak and a lack of fuel supply to the engine.
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
Prime-Time Specialty Vehicles (Prime-Time) is recalling certain 2023-2024 Ford Transit vehicles, 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."
Kia America, Inc. (Kia) is recalling certain 2022 Niro EV vehicles. The high voltage battery safety plug may overheat and melt, which can cause a loss of drive power or fire.
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Vermeer Manufacturing Company (Vermeer) is recalling certain 2015-2022 BC900XL brush chipper trailers. The service and maintenance manuals list the incorrect lug nut torque value.
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
FR Conversions is recalling certain 2023-2024 Ram Promaster vehicles, 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."
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Aluminum Trailer Company (ATC) is recalling certain 2021-2024 Toy Hauler 5th wheel trailers. The LED backlight circuit board in the cooktop range may fail, causing the board to overheat.
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.