China NMPA Product Recall - scalpel handle

On December 10, 2020, Shanghai Kangqiao Dental Medical Device Factory initiated a voluntary Class III recall of its surgical scalpel handles. This action followed a quality supervision spot check, which identified critical non-compliance issues. Specifically, the product failed to meet either mandatory national standards or the technical specifications outlined in its registered or filed documentation. This deficiency raised concerns about the product's quality and potential performance. The regulatory oversight for this recall is provided by the National Medical Products Administration (NMPA), with direct involvement from the Shanghai Municipal Drug Administration, ensuring appropriate measures are taken to protect public health. The affected surgical scalpel handles are identified by Registration Certificate No.: 沪浦械备20150128号. As a required action, Shanghai Kangqiao Dental Medical Device Factory must remove all non-conforming units from the market. Further detailed information regarding specific models, specifications, and batch numbers is available in the Medical Device Recall Event Report Form.