China NMPA Product Recall - Semiconductor laser therapy device

On December 9, 2021, Shanghai Leifukang Medical Equipment Co., Ltd. announced a voluntary Class III recall of its Semiconductor Laser Therapy Device, identified by Registration Certificate No.: 国械注准20173244013. This critical measure was prompted by the discovery of a non-compliant device during a national medical device sampling inspection conducted earlier in 2021. While the specific details regarding the non-compliance were not publicly disclosed in this announcement, the finding indicated a deviation from established quality or safety standards for the product. This recall operates within the regulatory framework of China's National Medical Products Administration (NMPA), the primary authority overseeing medical device safety and efficacy. The local notification was issued via the Shanghai Municipal Drug Administration, underlining the coordinated regulatory response. As a required action, the company is systematically recalling the affected devices, with comprehensive information on specific models, specifications, and batch numbers accessible through the "Medical Device Recall Event Report Form." This voluntary recall by Shanghai Leifukang Medical Equipment Co., Ltd. underscores the company's commitment to product safety and compliance with the stringent quality controls mandated by the NMPA, ensuring public health protection.