China NMPA Product Recall - Ultrasonic dental scaler

Guilin Yikeshi Medical Device Co., Ltd. initiated a voluntary recall of its ultrasonic dental scalers, a decision publicly announced by the National Medical Products Administration (NMPA) on May 25, 2020. The primary issue prompting this action was a printing error on the product label, specifically involving the registration certificate number (Gui Shi Yao Jian Xie (Zhun) Zi 2013 No. 2230111). This labeling inaccuracy represents a non-conformance with regulatory requirements, even if it does not directly affect the device's functionality. Operating under the regulatory framework of the NMPA, this recall is classified as Level 3. This classification indicates that while a defect exists, the use of or exposure to the affected product is unlikely to cause adverse health consequences. While specific inspection dates leading to this discovery are not provided in the document, the company's proactive, voluntary recall demonstrates a commitment to regulatory compliance. The required action for Guilin Yikeshi was to recall the affected ultrasonic dental scalers. Comprehensive details concerning the specific models, specifications, and batch numbers of the products subject to this recall were made available in an attached "Medical Device Recall Event Report Form". This ensured transparency and provided necessary information for stakeholders to manage the recall effectively.