China NMPA Product Recall - Disposable polyp removal device; disposable electric snare

On January 22, 2021, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall affecting specific batches of its disposable polyp removal devices and disposable electric snares. This action was prompted by a critical packaging defect where the single sterile packaging bag inside the product box had an incomplete seal. This flaw compromises the sterile barrier, potentially causing the devices to lose their sterile state before use. The National Medical Products Administration (NMPA) published this recall, highlighting its role in regulatory oversight for medical device safety. The affected products include various disposable polyp removal devices (Registration Certificate Nos.: 20173220892, 20173251147, 20193011633, 20193011635) and disposable electric snares (Registration Certificate No.: 20173256341). As a direct consequence, Boston Scientific is required to retrieve all implicated devices from the market to mitigate potential health risks. Further details regarding specific models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form" provided by the NMPA.