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All product recalls affecting North Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with North Dakota in the distribution area.
Nova Bus (US) Inc. (Nova) is recalling certain 2022-2023 LFS vehicles. Insufficient crimping may allow the secondary fuel filter hoses to disconnect and leak.
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Forest River, Inc. (Forest River) is recalling certain 2024 Aurora ART26BHS travel trailers. The breakaway switch may be incorrectly wired, preventing the breakaway switch from activating if the trailer detaches from the tow vehicle.
BMW of North America, LLC (BMW) is recalling certain 2024-2025 X5 xDrive40i vehicles. The tire information placard may indicate an incorrect tire size and tire pressure. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 110, "Tire Selection and Rims."
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Ford Motor Company (Ford) is recalling certain 2022-2024 Maverick, 2020-2022 Escape, and 2021-2022 Lincoln Corsair vehicles. The Hybrid Powertrain Control Module (HPCM) software may cause the vehicle to shift into neutral unexpectedly, causing a loss of drive power.
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.