China NMPA Product Recall - Disposable ECG electrodes

Shanghai Shenfeng Medical and Health Products Co., Ltd. initiated a voluntary recall of its Disposable ECG Electrodes following reports of adverse events. The recall, publicly reported on May 7, 2021, by the National Medical Products Administration (NMPA), addresses concerns stemming from 11 reported cases of allergic reactions experienced by users. Among these, 6 were classified as severe allergic reactions. The primary issue prompting this action is the potential for these electrodes to cause significant patient harm through unexpected allergic responses. The company's decision to voluntarily recall the product underscores its commitment to patient safety and adherence to product quality standards. Operating under the oversight of the NMPA, the recall has been designated as a Level III event, indicating a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. Shanghai Shenfeng Medical and Health Products Co., Ltd. is responsible for identifying and retrieving all affected batches of the Disposable ECG Electrodes (Registration Certificate No.: 沪械注准20172210564) from the market. Further detailed information regarding specific models, specifications, and batch numbers is available in the associated Medical Device Recall Event Report Form. This action ensures the removal of potentially harmful products and protects public health.