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All product recalls affecting Pennsylvania.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Pennsylvania in the distribution area.
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Volvo Trucks North America (Volvo Trucks) is recalling one 2025 New VN truck. A software error in the instrument cluster may cause the anti-lock brake system (ABS) warning light not to illuminate. As such, this vehicle fails to comply with the requirements of Federal Motor Vehicle Safety Standard number 121, "Air Brake Systems."
Mack Trucks, Inc. (Mack) is recalling certain 2020-2025 Anthem, Granite, TerraPro and Pinnacle vehicles, equipped with Bendix EC80 Advanced Electronic Control Units (ECU). Electrical noise and low signal to the power line carrier may cause the ECU to incorrectly process commands or stop working.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Volvo Trucks North America (Volvo Trucks) is recalling certain 2020-2025 VN, VAH, VHD and VNRE trucks, equipped with Bendix EC80 Advanced Electronic Control Units (ECU). Electrical noise and low signal to the power line carrier may cause the ECU to incorrectly process commands or stop working.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Failed Impurities/Degradation Specification
Failed Impurities/Degradation Specification
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
Triumph Motorcycles America, Ltd. (Triumph) is recalling certain 2022-2024 Bonneville T100, T120, T120 Black, 2022 Triumph Street Scrambler, Street Scrambler Sandstorm, Street Twin, Street Twin Goldline, 2023-2024 Scrambler 900, and Speed Twin 900 motorcycles. The wiring between the alternator and main harness connector may short circuit and overheat.
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
Vermeer Manufacturing Company (Vermeer) is recalling certain 2024-2025 VXT600G2 vacuum vehicles. Undersized welds on the lift supports may fail, allowing the spoil tank door to open.