China NMPA Product Recall - Disposable sterile vaginal speculum

Chongqing Xinyi Medical Device Co., Ltd. initiated a voluntary Level III recall of 21,600 units of its Disposable Sterile Vaginal Specula (Model B, Medium, Batch 1901012), produced on April 13, 2019. This recall, reported to the National Medical Products Administration (NMPA) on October 29, 2019, primarily affects Chongqing and Sichuan Provinces, China. The main issue stemmed from production adjustments, where some expander components exhibited slight diameter deviations of approximately one micrometer in specific holes. More critically, when the specula were expanded to their maximum setting and subjected to a 30N force, fasteners detached on certain products. This defect could compromise the device's stability and safe operation during gynecological examinations in medical institutions. Under NMPA oversight, the company implemented corrective actions requiring medical institutions and distributors to cease sales immediately. Return notices were issued, and all affected products were to be returned to Chongqing Xinyi Medical Device Co., Ltd. by June 30th for proper disposal. This action ensures patient safety by removing non-conforming devices from circulation.