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Showing 5701–5720 of 92420 results

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Volvo EX90 (Volvo) – Seat Bolt Issue (2024)

Volvo Car USA, LLC (Volvo Car) is recalling certain 2025 EX90 vehicles. The bolts for the second-row free-standing seat may not be tightened properly.

High

NHTSANov 19, 2024Nationwide• VOLVO

Levothyroxine Sodium 125mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 60mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Levothyroxine Sodium 100mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 150mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 20mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Levothyroxine Sodium 112mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 137mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 175mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 30mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Jeep Grand Cherokee (Chrysler) – Instrument Panel Error (2024)

Chrysler (FCA US, LLC) is recalling certain 2024 Jeep Grand Cherokee and Grand Cherokee L vehicles. A software error in the instrument panel cluster may cause the speedometer to display the incorrect vehicle speed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 101, "Displays and Controls."

High

NHTSANov 19, 2024Nationwide• JEEP

Mercedes Benz E500 (Mercedes Benz) – Sunroof Assembly (2024)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2001-2011 C-Class, CLK, E-Class, and CLS vehicles. Please see the recall report for a complete list of models and model years. The glass sunroof panel may not be properly secured and can detach.

High

NHTSANov 19, 2024Nationwide• MERCEDES BENZ

BMW 530i (BMW) – Airbag Control Unit (2024)

BMW of North America, LLC (BMW) is recalling certain 2025 530i and 540i xDrive vehicles. The air bag control unit may have been manufactured incorrectly, which can result in the air bags not deploying as intended.

High

NHTSANov 19, 2024Nationwide• BMW

Limitless Van Tire Mount (Limitless) – Weld Failure Risk (2024)

Limitless Van is recalling certain rear tire mounts. An improper weld may fail, allowing the rear tire mount to detach from the vehicle.

High

NHTSANov 18, 2024Nationwide• LIMITLESS VAN

Tec 820 ISO Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

High

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

EnVisio Patient Pad (Elucent) – Bed Frame Separation (2024)

There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.

Moderate

FDANov 18, 2024AZ, CA, CO +14 more• Elucent Medical Inc

Access hsTnI Reagent (Beckman Coulter) – Troponin Level (2024)

Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.

Moderate

FDANov 18, 2024Nationwide• Beckman Coulter, Inc.

Tec 850 SEV Vaporizer (GE Medical) – Anesthetic Delivery (2024)

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

High

FDANov 18, 2024Nationwide• GE Medical Systems, LLC

Hudson RCI mBrace (Medline) – Adhesive and Pressure Issue (2024)

Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.

Moderate

FDANov 18, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Genesis GV70 Electrified (Genesis) – Charging Module (2024)

Hyundai Motor America (Hyundai) is recalling certain 2022-2024 IONIQ 5, 2023-2025 IONIQ 6, Genesis GV60, Genesis GV70 "Electrified," and Genesis G80 "Electrified" vehicles. The Integrated Charging Control Unit (ICCU) may become damaged and stop charging the 12-volt battery, which can result in a loss of drive power.

High

NHTSANov 18, 2024Nationwide• GENESIS

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