China NMPA Product Recall - Disposable sterile vaginal speculum

Taizhou Kangjian Medical Device Co., Ltd. has initiated a voluntary Class III recall of its Disposable Sterile Vaginal Specula (Registration Certificate No.: Zhexiezhuzhun 20182660018). This action, publicly reported on January 17, 2019, follows national medical device supervision and spot checks conducted by the National Medical Products Administration (NMPA) through the Jiangsu Provincial Food and Drug Administration. Sampling inspections on product batches 20180205 and 20180414 revealed that the devices failed to meet required structural strength standards, as detailed in reports G20181436 and G20181437. In response, the company issued an emergency notice on September 25, 2018, to halt sales of the affected batches, totaling 20,000 units produced. Taizhou Kangjian Medical Device Co., Ltd. has completed corrective actions, including implementing the recall procedures for these batches. The company is now actively collaborating with drug regulatory authorities to ensure the proper disposal of remaining inventory, which includes 5600 units from batch 20180205 and 8000 units from batch 20180414, in adherence to the established regulatory framework for medical device safety and quality.