China NMPA Product Recall - sterilizer

On July 12, 2019, Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its sterilizer products, identified by Registration Certificate No.: 20172577114. This action was prompted by the manufacturer's discovery of a potential issue with the equipment's pressure sensor. The defect could compromise the sterilizers' intended operation under specific circumstances, raising concerns about product performance and safety. The recall announcement, referenced as Shanghai Food and Drug Administration Medical Device Recall 2019-162, falls under the regulatory oversight of the National Medical Products Administration (NMPA). Maikewei (Shanghai) Medical Equipment Co., Ltd. confirmed that, as of the recall date, no complaints or adverse event reports related to this specific pressure sensor problem had been received. This proactive measure ensures that potentially affected devices are addressed to uphold safety standards and product efficacy within the medical device market.