China NMPA Product Recall - Disposable sterile vaginal speculum

Nanchang Tongda Medical Device Co., Ltd. initiated a voluntary recall of its disposable sterile vaginal specula, as announced by the National Medical Products Administration (NMPA) on January 10, 2020. The company's decision stemmed from the medical devices failing to meet established standard requirements. While the specific details of the non-compliance were not elaborated in the public announcement, it indicated a failure to adhere to required quality or safety specifications for the product (Registration Certificate No.: Gan Shi Yao Jian Xie (Zhun) Zi 2014 No. 2660274). The public notice did not specify the recall level. This action is overseen by the NMPA, the regulatory body responsible for medical device safety and efficacy in China. Nanchang Tongda Medical Device Co., Ltd. is undertaking the necessary steps to remove the non-conforming products from the market. Further detailed information regarding the affected models, specifications, and batch numbers is available in a supplementary "Medical Device Recall Event Report Form."