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All product recalls affecting North Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with North Dakota in the distribution area.
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.
Presence of foreign tablets/capsules.
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Ford Motor Company (Ford) is recalling certain 2022 F-150 Lightning BEV vehicles equipped with 20" or 22" all season tires that were repaired incorrectly under recall 22V-453. The tire pressure monitoring system (TPMS) light may not illuminate as intended, failing to warn the driver of low tire pressure. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 138, "Tire Pressure Monitoring Systems."
Ford Motor Company (Ford) is recalling certain 2021 F-150 vehicles equipped with the Onboard Scales feature that were repaired incorrectly under recall 24V443. An over-the-air software update to the body control module (BCM) may have disabled both reverse lights.
Ford Motor Company (Ford) is recalling certain 2022-2023 Transit vehicles previously repaired incorrectly under recall number 22V415. The Instrument Panel Cluster may not properly illuminate warning lights or gauges. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 101, "Control and Displays."
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to complaints, software update may cause software to unexpectedly shutdown.