China NMPA Product Recall - Disposable medical surgical gowns

On July 6, 2021, Sichuan Hengming Technology Development Co., Ltd. initiated a voluntary Class III recall for specific batches of its disposable medical surgical gowns. This action followed a 2021 national medical device spot check, which revealed that products failed to meet the required technical standards. Specifically, tested samples did not comply with the product technical requirements outlined in the company's registration certificate, "Sichuan Medical Device Registration Certificate No. 20182640098." The recall is being managed by the Sichuan Provincial Drug Administration, operating under the broader regulatory framework of the National Medical Products Administration (NMPA). A Class III recall indicates that the use of or exposure to the violative product is not likely to cause adverse health consequences. Sichuan Hengming Technology Development Co., Ltd. took this measure to address the identified non-compliance, demonstrating a commitment to product safety and adherence to established medical device standards. Detailed information regarding the affected models, specifications, and batch numbers is available in the accompanying "Medical Device Notice" and "Medical Device Recall Event Report Form," facilitating the identification and return of non-conforming products.