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All product recalls affecting North Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with North Dakota in the distribution area.
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Chrysler (FCA US, LLC) is recalling certain 2017-2020 Fiat 124 Spider vehicles. A software error in the air bag control module may cause the front air bags to deploy with excessive force during a crash. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
Mazda North American Operations (Mazda) is recalling certain 2016-2023 MX-5 Miata vehicles. A software error in the air bag control module may cause the front air bags to deploy with excessive force during a crash. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Trans Tech Bus (Trans Tech) is recalling certain 2018-2021 SST, CST, SSTFLR and CSTFLR school buses. In the event of a rollover, the emergency exit windows may not open. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 220, "School Bus Rollover Protection."
Goodyear Tire & Rubber Company (Goodyear) is recalling certain Hercules Terra Trac AT X-Venture tires, size LT265/75R16. The tires contain a tire identification number (TIN) that is missing the 4-digit week and year code mark. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 574, "Tire Identification & Recordkeeping."
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.
Due to pin coming off of handles.
A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery
The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
Kia America, Inc. (Kia) is recalling certain 2024 EV9 vehicles. A software error may cause the remote smart parking assist feature, which allows the operator to remotely move the vehicle, to miscalculate stopping distances.
There is discrepant labeling on the inner and outer packaging of the device.
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
Harley-Davidson Motor Company (Harley-Davidson) is recalling certain 2024 FLHX, FLHXSE, FLTRX, FLTRXSE, and FLTRXSTSE motorcycles. The voltage regulator output wire may rub on the front corner of the crankcase, exposing the wire and causing an electrical short circuit. A short can result in a loss of electrical power and drive power.