China NMPA Product Recall - Disposable sterile vaginal speculum

Chongqing Xinyi Medical Device Co., Ltd. initiated a voluntary Class III recall for 21,600 units of its disposable sterile vaginal specula (model Medium, Type B, batch number 1901012). This action was formally reported on October 29, 2019, and falls under the regulatory oversight of China's National Medical Products Administration (NMPA).The recall was prompted by manufacturing irregularities identified during production department adjustments, including issues related to mold debugging. Investigations revealed significant defects: the expander components exhibited slight diameter deviations, being approximately one micrometer larger than specified. Furthermore, when the speculum was expanded to its maximum setting, a force of 30N caused fasteners on some units to detach, indicating a potential compromise in device integrity. Affected products were manufactured on April 13, 2019, and distributed in Chongqing and Sichuan Provinces.As required actions, Chongqing Xinyi Medical Device Co., Ltd. issued return notices to all affected medical institutions and distributors, mandating a halt to further sales of the non-compliant devices. All recalled items were to be promptly returned to the company for proper disposal, ensuring patient safety and compliance with medical device standards.