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All product recalls affecting Montana.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Montana in the distribution area.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Micro DOT Helmet Co. (Micro DOT) is recalling certain Blister and Twister original helmets, sizes XXS - XXL. The helmets may lack proper penetration protection. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 218, "Motorcycle Helmets."
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Lack of sterility assurance.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Ford Motor Company (Ford) is recalling certain 2020-2021 Lincoln Aviator vehicles equipped with 3.0L PHEV engines that were repaired incorrectly under recall 23V626. A manufacturing defect in one or more of the high voltage battery cells may result in an internal short circuit and battery failure.
Ford Motor Company (Ford) is recalling certain 2024 Nautilus vehicles. The multimedia module software may cause the panoramic and center displays to reboot, resulting in a blank screen. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) numbers 111, "Rear Visibility," and 102, "Transmission shift lever sequence, starter interlock, and transmission braking effect," as well as FMVSS numbers 126, 108, 135, 138, 208, 101, and 305.
Ford Motor Company (Ford) is recalling certain 2018-2020 Expedition and Lincoln Navigator vehicles. The seat belt pretensioner in the driver and/or front passenger seat may inadvertently lock the seat belt, which will not allow the belt to retract or extend.
Ford Motor Company (Ford) is recalling certain 2016-2017 Explorer vehicles. The driver and front passenger B-Pillar door trim may detach while driving.
Ford Motor Company (Ford) is recalling certain 2020-2023 Lincoln Aviator and Lincoln Corsair vehicles equipped with a Revel Audio System that were repaired incorrectly under recall 22V-953. When the driver's seat belt is not buckled and the vehicle is started, the seat belt warning system may activate the audible warning chime for an insufficient amount of time of less than 4 seconds. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Ford Motor Company (Ford) is recalling certain 2020 Expedition and Navigator vehicles that were repaired incorrectly under recall 20V262. The Pre-Collision Assist features, such as forward collision warning and automatic emergency braking, are not functional due to a software error.
Ford Motor Company (Ford) is recalling certain 2024-2025 F-150 Lightning BEV vehicles. The front upper control arm ball joint nut may not have been tightened properly, allowing the front upper control arm to detach from the knuckle assembly.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.