China NMPA Product Recall - scalpel handle

Shanghai Kangqiao Dental Medical Device Factory initiated a voluntary Class III recall of its surgical knife handles, effective December 10, 2020. This action was prompted by quality supervision spot checks that identified a critical non-conformance for product batch number 20-03, manufactured on May 8, 2020. The primary issue was the product's failure to meet mandatory national standards and its own registered technical specifications, indicating a potential compromise in product quality and safety.The recall was issued under the regulatory framework of China's National Medical Products Administration (NMPA) and publicized through the Shanghai Municipal Drug Administration Website. The company's required action was to voluntarily remove the affected surgical knife handles (Registration Certificate No.: 沪浦械备20150128号) from circulation. This measure was taken to protect user interests and mitigate potential risks associated with using substandard medical devices. Detailed information regarding the specific models, specifications, and all involved batches was provided in an accompanying "Medical Device Recall Event Report Form," guiding stakeholders on the necessary actions to be taken.