China NMPA Product Recall - Suction/irrigation instruments for endoscopic surgery

On April 15, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Covidien LLC. This recall, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd., involves specific models and batches of endoscopic suction/irrigation instruments. The main issue prompting this action was the discovery of foreign objects within the packaging of these medical devices. While specific inspection dates are not detailed, the recall notification was published on the mentioned date. Under the NMPA's regulatory framework for medical devices, Covidien LLC is undertaking the required action of a voluntary recall to address this quality concern. Detailed information regarding affected product models, specifications, and batch numbers is provided in an accompanying "Medical Device Recall Event Report Form."