China NMPA Product Recall - Far-infrared magnetic therapy patch

On July 1, 2021, Anhui Jintai Medical Device Co., Ltd. initiated a voluntary Class III recall of its far-infrared magnetic therapy patches, identified by registration number "皖械注准20192090180". This decisive action was prompted by the discovery of a critical quality issue: the product exhibited "substandard magnetic induction intensity." This deficiency potentially compromises the intended therapeutic efficacy and overall performance of the medical device, making it non-compliant with established quality specifications.

The recall was officially reported through the National Medical Products Administration (NMPA) under index number JGXX-2021-10334, highlighting the NMPA's role in regulatory oversight to safeguard public health and product integrity. A Class III recall indicates that while the identified issue is unlikely to cause serious adverse health consequences, it necessitates the removal of the affected products from the market to correct the non-conformity.

Anhui Jintai Medical Device Co., Ltd. undertook this recall as a proactive measure, demonstrating its commitment to product quality and patient safety. Comprehensive details regarding the specific models, specifications, and batch numbers of the affected patches are documented in the "Medical Device Incident Report Form," which provides essential information for stakeholders. This event underscores the rigorous standards within the medical device industry and the continuous monitoring required to ensure product reliability.