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Showing 3401–3420 of 4465 results

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Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

ZF North America Brake Chamber (ZF) – Brake Replacement (2025)

Fire/Burn Risk

Nova Bus (US) Inc. (Nova Bus) is recalling certain ZF North America Knorr-Bresme 20/22-57 brake chambers, with part number K038830N00, sold as replacement parts for certain buses. The brake chamber may have been improperly manufactured, which can result in an air leak.

High

NHTSAApr 14, 2025Nationwide• ZF NORTH AMERICA

Microtek Patient Drape (Microtek) – Sterility Concern (2025)

Due to non-sterile products being labeled as sterile

FDAApr 13, 2025AL, AR, CA +17 more• Microtek Medical, Inc.

iGo2 DC Car Adapter (Medical Depot) – Power Supply Risk (2025)

Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

FDAApr 11, 2025Nationwide• Medical Depot Inc.

TufTex Embolectomy Catheter (LeMaitre) – Seal Integrity (2025)

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

FDAApr 11, 2025Nationwide• LeMaitre Vascular, Inc.

Ford Ranger (Ford) – Window Control Repair (2025)

Ford Motor Company (Ford) is recalling certain 2024 Ranger and 2024 Lincoln Nautilus vehicles previously repaired incorrectly under recall number 24V-597. When closing the windows with the global closing feature, the windows may not automatically reverse after detecting an object. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 118, "Power-Operated Window Systems."

NHTSAApr 11, 2025Nationwide• FORD

Centerline IOPS Guidewire (Centerline) – Coating Failure (2025)

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

FDAApr 11, 2025FL, NM, NY +5 more• Centerline Biomedical Inc

Ford Expedition (Ford) – Brake Master Cylinder (2025)

Ford Motor Company (Ford) is recalling certain 2017-2018 F-150, Expedition, and Lincoln Navigator vehicles. The brake master cylinder may allow brake fluid to leak from the front wheel circuit into the brake booster.

NHTSAApr 11, 2025Nationwide• FORD

Ford Transit (Ford) – Rearview Camera (2025)

Ford Motor Company (Ford) is recalling certain 2022-2023 Transit vehicles previously repaired incorrectly under recall number 23V-598. The rearview camera, or 360-degree view camera if equipped, may not display a rearview image when the vehicle is placed in reverse.

NHTSAApr 11, 2025Nationwide• FORD

Codman Craniotomy Kit (Integra) – Weld Integrity (2025)

Inadequate weld that can potentially cause the product to disassemble.

FDAApr 11, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Entegra Anthem (Jayco) – Fuel Filter Issue (2025)

Jayco, Inc. (Jayco) is recalling certain 2025 Entegra Aspire, 2025-2026 Entegra Anthem, and Cornerstone motorhomes. The fuel filter housing may become damaged from contact with the rear cap support bracket, causing a fuel leak.

NHTSAApr 11, 2025Nationwide• ENTEGRA

Mercedes-Benz E 350 (Mercedes-Benz) – Wiring Concern (2025)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2024 E 350 4MATIC, E 450 4MATIC All-Terrain, and E 450 4MATIC vehicles. The 12-Volt and 48-Volt ground connections for the electrical wiring harness may not be secured properly, resulting in the ground connections overheating.

NHTSAApr 11, 2025Nationwide• MERCEDES-BENZ

Pruitt Occlusion Catheter (LeMaitre) – Seal Integrity (2025)

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

FDAApr 11, 2025Nationwide• LeMaitre Vascular, Inc.

Pruitt Irrigation Catheter (LeMaitre) – Seal Integrity (2025)

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

FDAApr 11, 2025Nationwide• LeMaitre Vascular, Inc.

Ford E-Transit Chassis (Ford) – Battery Pack Rails (2025)

Ford Motor Company (Ford) is recalling certain 2024-2025 E-Transit Chassis Cab vehicles. The tray side rails for the high voltage battery pack may buckle and crack, allowing water to enter the battery.

NHTSAApr 11, 2025Nationwide• FORD

Codman Disposable Perforator (Integra) – Weld Integrity (2025)

Inadequate weld that can potentially cause the product to disassemble.

FDAApr 11, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Ford Explorer (Ford) – Powertrain Control Module (2025)

Ford Motor Company (Ford) is recalling certain 2025 Explorer vehicles. The powertrain control module (PCM) may reset while driving, which can damage the park system or cause an engine stall.

NHTSAApr 11, 2025Nationwide• FORD

MedicaLyte Bicarbonate (Nipro) – Foreign Matter Risk (2025)

Potential for the presence of visible foreign matter.

FDAApr 11, 2025Nationwide• Nipro Renal Soultions USA, Corporation

CMS8000 Patient Monitor (Contec) – Cybersecurity Risk (2025)

Patient monitor has nine identified cybersecurity vulnerabilities.

FDAApr 10, 2025Nationwide• Contec Medical Systems Co., Ltd. Economic And No.

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