China NMPA Product Recall - Disposable sterile vaginal speculum

Chongqing Xinyi Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable sterile vaginal specula (registration number "渝械注准20182180120") due to identified manufacturing defects. The National Medical Products Administration (NMPA) and the Chongqing Municipal Drug Administration publicly announced the recall on October 22, 2020, referencing a recall event report dated October 29, 2019. The affected products, specifically "Medium Type B" specula from batch number 1901012, produced on April 13, 2019, comprised 21,600 units distributed in Chongqing and Sichuan Provinces. The primary issues included a slight deviation in the blade aperture of the dilator component, with one or two holes being approximately one micrometer larger than standard. Furthermore, fasteners on some specula were found to loosen when subjected to a 30N force at maximum expansion. In response, Chongqing Xinyi Medical Device Co., Ltd. issued return notices to all affected medical institutions and businesses, prohibiting further sales. These entities were instructed to return the defective products by June 30th, after which the company would manage their proper disposal. This action demonstrates adherence to the regulatory framework ensuring medical device safety and quality.