China NMPA Product Recall - High-speed air turbine mobile phone

W&H Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its high-speed air turbine handpieces, model TE-97 LQ, as reported on November 9, 2020, through the Shanghai Municipal Drug Administration. The primary issue identified was that the product's maximum no-load speed did not meet its defined technical requirements, with tested speeds found to be lower than specified. However, the company clarified that this technical discrepancy did not affect patient safety or the core functionality of the device. The decision for this voluntary recall by W&H China was made to ensure better compliance with Chinese regulations. It was determined that the company's internal standard for working pressure was set significantly higher than industry-standard values, contributing to the observed deviation. The required action involves the recall of the affected high-speed air turbine handpieces, with specific details on models, specifications, and batches provided in an associated "Medical Device Recall Event Report Form." This proactive measure reflects the company's commitment to meeting national medical device standards.