China NMPA Product Recall - Heating pad therapy device

Henan Siyuan Medical Device Co., Ltd. initiated a voluntary Level III recall of its heating pad therapy devices (model SY-T02A, production date September 20, 2018), as announced by the National Medical Products Administration (NMPA) on September 30, 2020. The recall was prompted by findings from sampling and testing conducted in 2020 by the Tianjin Medical Device Quality Supervision and Inspection Center. These tests revealed that the devices failed to comply with the mandated requirements for their instruction manuals and product nameplates. The main violation centered on the non-compliance of product labeling and user instructions, which are critical for safe and effective use. This recall affects one specific batch, comprising 28 units, distributed within China. Under the regulatory oversight of the NMPA, Henan Siyuan Medical Device Co., Ltd. is required to undertake several corrective actions. These include notifying all purchasers and users to cease selling and using the affected batch immediately. Furthermore, the company must retrieve all non-compliant products from the market, ensure their destruction, and conduct a thorough investigation into the root cause of the non-compliance. Following this investigation, the company is mandated to develop and effectively implement corrective and preventive measures to prevent recurrence.