China NMPA Product Recall - Thermoelectric Therapy Device

The Jilin Provincial Drug Administration announced a Level III recall for thermoelectric therapy devices manufactured by Yanji Kexian Medical Device Co., Ltd. This decision followed routine supervision and sampling inspections conducted by the Shanghai Municipal Drug Administration, which identified that devices from a specific batch were non-compliant and failed inspection. The primary issue was the product's failure to meet established quality standards, leading to its non-compliance. In response to these findings, Yanji Kexian Medical Device Co., Ltd. proactively initiated a recall of the affected products. This action was taken in accordance with the "Regulations on the Management of Medical Device Recalls" and other relevant regulatory guidelines, underscoring the commitment to ensuring the quality and safe use of medical device products. Further details regarding the specific batch and non-compliance are documented in the "Medical Device Recall Event Report Form."