China NMPA Product Recall - Foot bath therapy massager

Shandong Longma Health Products Co., Ltd. initiated a voluntary Class III recall of its foot bath therapy massager (Registration No.: 20132260308). This action, published by the National Medical Products Administration (NMPA) on November 28, 2017, followed the identification of a significant safety concern. During routine random inspections, which likely occurred around September to October 2017, the product was found to have unqualified leakage current values. This electrical safety issue presents a potential risk to users, indicating a failure to meet established safety standards for medical devices. The NMPA serves as the regulatory authority overseeing this recall. As a required action, the company is voluntarily removing the affected products from the market to mitigate potential hazards. The specific models, specifications, and batch numbers included in the recall are detailed in the accompanying "Medical Device Recall Event Report Form," ensuring comprehensive identification of the impacted units. The Class III classification suggests that while the product's use may cause temporary or reversible adverse health consequences, the likelihood of serious harm is considered remote.