China NMPA Product Recall - Specific Electromagnetic Wave (TDP) Therapy Device

Chongqing Hualun Hongli Industrial Co., Ltd. initiated a voluntary Class III recall for specific electromagnetic wave therapy devices (Model CQH-25A, Batch 1801041) produced on January 9, 2018. This action, reported to the Provincial Food and Drug Administration Department on January 2, 2020, was undertaken because the devices did not meet essential "voltage and/or energy limitations" requirements, posing potential safety hazards. Under the oversight of the National Medical Products Administration (NMPA), the company decided to control defective products and eliminate risks. The regulatory framework involves adherence to medical device standards. As a required action, Chongqing Hualun Hongli Industrial Co., Ltd. issued "Medical Device Recall Notices" to its sales units. Medical institutions and operating units are instructed to follow the requirements outlined in these customer notifications. Notably, this voluntary recall does not entail the physical withdrawal of affected products from the market, suggesting that the corrective action involves notification and potential user-level adjustments rather than product retrieval. This aims to ensure product safety and compliance.