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All product recalls affecting Delaware.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Delaware in the distribution area.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Brinkley RV (Brinkley) is recalling certain 2025 Model Z travel trailers. The installed safety chains are underrated for the Gross Vehicle Weight Rating (GVWR).
Tesla, Inc. (Tesla) is recalling certain 2024 Cybertruck vehicles. The rearview camera image may be delayed after shifting into reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 111, "Rear Visibility."
Harley-Davidson Motor Company (Harley-Davidson) is recalling certain 2018-2019 Softail FXBB Street Bob and 2018-2019 Softail FXLR Low Rider motorcycles. The front tire inflation pressure on the VIN label may be less than the stated front gross axle weight rating (GAWRs). As such, these motorcycles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 120, "Wheels and Rims - Other than Passenger Cars."
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
The recall involves Multi-Grip Tub Safety Bars sold under the brands Peerless, model PL585; Safety First, models SF585 and S1F585; and Delta, model DF585. The recalled Multi-Grip Tub Safety Bars are powder-coated aluminum, were sold in the color white, and feature a one-inch diameter tube with two gripping surfaces at about 8 inches and 15 inches. The model number and brand name are listed on a label on the product's packaging.
This recall involves 1023E, 1025R and 2025R Compact Utility Tractors with the model number and "John Deere" printed on the hood. The recalled tractors are green and yellow, and were sold with both opened and closed operator stations. The serial numbers of tractors included in this recall can be found at www.deere.com. Click on "Parts & Service" and scroll to "Recall" or go to www.deere.com/en/parts-and-service/recall-information/. The serial number is located on the frame, on the front right side of the tractor, near the engine.
Out of specification endotoxin levels.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
BMW of North America, LLC (BMW) is recalling certain 2023-2024 228i, 228i xDrive, and 2025 MINI Countryman S ALL4 vehicles. The bolts that connect the front body structure to the vehicle chassis may not have been tightened properly.
General Motors, LLC (GM) is recalling certain 2024 Buick Envision vehicles. The vehicles are missing the label that states the tire size, pressure, and the loading information. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 110, "Tire Selection and Rims."
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Tenneco Automotive (DRiV) is recalling certain aftermarket ball joints for 2013-2019 Ford Escape vehicles, MOOG part numbers K500346, K500347, NAPA part numbers 2601878 and 2601879. The ball joint may separate between the mounting flange and socket.
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
BMW of North America (BMW) is recalling certain 2024-2025 530i xDrive, 540i xDrive, 2024-2025 i5 eDrive40, i5 M60 xDrive, 2025 i5 xDrive40, 2024 740i xDrive, 760i xDrive, 750e xDrive, i7 eDrive50, i7 xDrive60, and i7 M70 xDrive vehicles. The steering spindle may break requiring a greater steering effort to control the vehicle.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.