China NMPA Product Recall - Ultrasonic dental scaler

Nanning Baolai Medical Device Co., Ltd. initiated a voluntary Class III recall for its ultrasonic dental scalers, model P5L, with the recall announced on October 12, 2021. This action was prompted by identified inconsistencies between the technical specifications detailed in the product's instruction manual, power label, and gift box, and the actual technical requirements of the device. The recall specifically targets products from batch number P5L21022601 and includes several associated product numbers. The regulatory framework overseeing this recall includes the National Medical Products Administration (NMPA) and the Guangxi Zhuang Autonomous Region Drug Administration. As a Class III recall, it indicates that while there are non-conformities in the product information, the use or exposure to the device is not expected to cause adverse health consequences. The required action for Nanning Baolai Medical Device Co., Ltd. is to retrieve affected units from the market to correct these documentation and labeling discrepancies, ensuring accurate product representation.