China NMPA Product Recall - Circular hemorrhoid stapler

On December 19, 2018, the National Medical Products Administration (NMPA) announced a significant voluntary Class II recall initiated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This recall specifically targets certain batches of the company's circular hemorrhoid staplers. The core issue identified is a manufacturing defect where some devices may fail to achieve a complete cut after deployment, posing a direct risk of patient bleeding or soft tissue damage. Investigations have linked this critical malfunction to the potential absence of a cutting gasket during the assembly process of the affected batches. Despite no related complaints or adverse events being reported within China up to the announcement date, Johnson & Johnson proactively undertook this action to uphold patient safety. Under the strict guidance of the NMPA, and with support from the Shanghai Food and Drug Administration, the required action is the immediate removal of all identified product models, specifications, and batches from the market. This voluntary recall underscores the company's commitment to compliance with China's medical device regulatory framework and to ensuring product reliability for healthcare providers and patients. Detailed information regarding the precise models and batches involved is accessible in the official "Medical Device Recall Event Report Form."