China NMPA Product Recall - Automated External Defibrillator

Physio-Control, Inc., a medical device manufacturer, has initiated a voluntary Class III recall of specific batches of its Automated External Defibrillator. This recall, reported by Stryker (Beijing) Medical Devices Co., Ltd. to the National Medical Products Administration (NMPA) on February 2, 2026, addresses a critical product defect. The primary issue identified is the conductive adhesive separation of the defibrillator electrodes, which could compromise the device's functionality. This regulatory action is overseen by the NMPA in China, highlighting the framework for ensuring medical device safety and quality. The required action involves the voluntary recall of affected batches, with detailed information on specific models and specifications available in an accompanying Medical Device Recall Event Report Form. This measure underscores the company's commitment to compliance and patient safety within the NMPA's regulatory environment.