China NMPA Product Recall - Ultrasonic dental scaler

Guilin Yikeshi Medical Device Co., Ltd. initiated a voluntary Class III recall of its ultrasonic dental scalers, as announced on May 25, 2020. This action was prompted by a printing error in the registration certificate number displayed on the product labels. The affected products bear Registration Certificate No.: Gui Shi Yao (Zhun) Zi 2013 No. 2230111. The recall, overseen by the National Medical Products Administration (NMPA) and specifically highlighted by the Guangxi Zhuang Autonomous Region Drug Administration, addresses a labeling discrepancy rather than a product safety or performance issue. The company is undertaking this recall to ensure compliance with regulatory standards for medical device labeling in China. A Class III recall typically signifies a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. Details regarding the specific models, specifications, and batches subject to this recall are documented in the "Medical Device Recall Event Table" and the "Medical Device Recall Event Report Form." Guilin Yikeshi Medical Device Co., Ltd. is responsible for managing the retrieval and correction of the mislabeled devices to ensure accuracy and adherence to national medical product regulations. This proactive measure demonstrates the company's commitment to regulatory compliance.