China NMPA Product Recall - Breathing circuit; disposable heat exchanger/filter; disposable heat exchanger; filter; closed suction device; oropharyngeal airway; closed suction device

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of multiple medical devices, including breathing circuits, disposable heat exchangers/filters, and closed suction devices. Announced on June 7, 2021, through the National Medical Products Administration (NMPA), the recall was prompted by a report from Medtronic's former supplier, Stell Milano. The report indicated a potential temperature and humidity deviation at an ethylene oxide sterilization site. While Covidien assessed that the deviation did not impact the sterility, packaging, or functionality of most products, a critical issue emerged for a specific batch where sterilization process data was missing, preventing confirmation of its sterility. Despite no reported adverse events or complaints globally, and the conclusion that the issue would not cause additional patient harm, Covidien proactively conducted the recall. This action underscores the company's commitment to maintaining product safety and regulatory compliance under the NMPA's framework. Detailed information on affected models and batches is provided in the "Medical Device Recall Event Report Form."