China NMPA Product Recall - Bravo pH Monitoring System

Given Imaging, Inc. has initiated a voluntary Class I recall of its Bravo pH Monitoring System, as reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The recall, publicly announced on September 5, 2025, addresses a critical product issue involving the potential malfunction of the capsule delivery device. This malfunction is attributed to adhesive material on the device, which could compromise its intended function and patient safety. The Bravo pH Monitoring System, registered under National Medical Device Registration Certificate 20153073986, is subject to this recall under the oversight of the National Medical Products Administration (NMPA) of China. A Class I recall designation signifies that there is a reasonable probability that using the affected product could cause serious adverse health consequences or even death. As a result, Given Imaging, Inc. is taking corrective action to mitigate potential risks to patients and healthcare providers. The specific models, specifications, and batch numbers of the affected devices are detailed in an accompanying Medical Device Recall Event Report Form, which provides comprehensive information for all relevant stakeholders. This proactive measure aims to ensure patient safety and uphold product quality standards within the medical device industry. Users and distributors are advised to consult the official report for further guidance on the recall process.