China NMPA Product Recall - Ultrasonic biopsy needle, high-resolution ultrasonic biopsy needle

The National Medical Products Administration (NMPA) announced on April 17, 2024, a voluntary Class II recall initiated by Cook Ireland Limited for specific ultrasound biopsy needles. Cook (China) Medical Trading Co., Ltd. reported this action, which involves the EchoTip Ultra Endoscopic Needle (National Medical Device Registration Certificate 20152020414) and the ECHOTIP Ultra High Definition Ultrasound Access Needle (National Medical Device Registration Certificate 20152021702). The primary reason for this recall is the detection of excessive bacterial endotoxins in the affected products. This issue poses a potential health risk to patients, prompting the manufacturer to take corrective action. Detailed information, including specific product models, specifications, and batch numbers, is available in the "Medical Device Recall Event Report Form" provided by Cook (China) Medical Trading Co., Ltd. This recall demonstrates the NMPA's commitment to ensuring the safety and quality of medical devices within its regulatory framework, requiring manufacturers to address identified product deficiencies proactively to protect public health.