China NMPA Product Recall - Single-use endoscopic ultrasound aspiration biopsy needle

Gyrus ACMI, Inc., with reporting by Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class I recall for its Single-Use Endoscopic Ultrasonic Aspiration Biopsy Needle, announced on September 12, 2025. The recall stems from critical product issues, specifically the potential for a dislodged hypotube or plastic detachment within the device. These malfunctions represent a significant safety risk, warranting the highest classification of recall by regulatory authorities. This action falls under the stringent regulatory framework of the National Medical Products Administration (NMPA) of China, which oversees medical device safety and compliance. Although specific inspection dates are not detailed, the recall itself serves as the immediate regulatory response to the identified product defects. Gyrus ACMI, Inc. is required to undertake a comprehensive voluntary recall of all affected product models, specifications, and batch numbers. This critical measure, outlined in the NMPA's public notice (Index No.: JGXX-2025-10124), aims to prevent potential adverse health consequences for patients and uphold the integrity of medical devices available in the market. Manufacturers are expected to adhere to NMPA guidelines by reporting such issues and implementing necessary corrective actions to safeguard public health.