China NMPA Product Recall - Hernia repair device

On May 19, 2020, the National Medical Products Administration (NMPA) in China announced a voluntary recall initiated by Covidien LLC, a medical device manufacturer. This action was reported by Covidien Medical Devices Trading (Shanghai) Co., Ltd. The recall pertains to specific models and batches of hernia repair devices due to potential manufacturing and assembly errors. These identified errors could lead to operational failures of the devices during clinical use, posing a safety concern. The recall is classified as Level III, indicating that the use of or exposure to the affected product is not likely to cause adverse health consequences. While the NMPA published this announcement in 2020, the recall itself references a China Food and Drug Administration (CFDA) identification from 2011, suggesting it may be a revised or ongoing recall. Covidien LLC is implementing this voluntary action to address the product deficiencies. Further detailed information regarding the affected product models, specifications, and batch numbers is available in an attached "Medical Device Recall Event Report Form," overseen by the NMPA's regulatory framework to ensure medical device safety and quality in China.