China NMPA Product Recall - Large manual vertical steam sterilizer (KYQL-98DS)

Zibo Kangyuan Sanitary Equipment Co., Ltd. initiated a voluntary Class III recall for its Large Manual Vertical Steam Sterilizer (Model KYQL-98DS) following a national medical device quality supervision and spot check. This action, reported on December 20, 2019, under the regulatory oversight of the National Medical Products Administration (NMPA), was prompted by critical safety failures. Specifically, the device's safety interlock mechanism and synchronous alarm function were found to be substandard, posing potential hazards to users and compromising the efficacy of sterilization processes. The company identified and recalled four affected units from production batch 2018-83167, along with an additional unit (product number 2017-87073) previously deployed at Fangcun Town Health Center. To address these deficiencies, Zibo Kangyuan Sanitary Equipment Co., Ltd. undertook on-site corrective actions, which included debugging, repairing, and replacing necessary parts. The successful resolution of these issues was subsequently confirmed by the user facilities, with all affected devices brought into compliance by September 17, 2019.