Loading...
Loading...
All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
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.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Great Dane Trailers (Great Dane) is recalling certain 2025 Champion Dry Van trailers. The rear impact guard may have been welded improperly.
Ford Motor Company (Ford) is recalling certain 2022-2024 Ford Maverick vehicles equipped with Connected Touch Radios (CTR). The rearview camera image may freeze when the vehicle is in reverse.
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
There is a defect in the air-in-line software algorithm.
Ford Motor Company (Ford) is recalling certain 2022 F-150 vehicles. The parking lights may flicker when the headlights are activated. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."