China NMPA Product Recall - Hydrogen peroxide low-temperature plasma sterilization system

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level II recall for specific models of its Hydrogen Peroxide Low-Temperature Plasma Sterilization Systems, particularly model 10033. This action, reported to the National Medical Products Administration (NMPA) on January 17, 2017, and published on February 21, 2017, arose from an internal evaluation by the parent company. The core safety issue identified is that after an external power outage, the system's door lock might temporarily loosen for 20 seconds during restart. This momentary vulnerability could potentially expose users to a hazardous concentration of hydrogen peroxide, posing a risk of injury. Of the 350 units imported into China, 339 had been sold; however, no related complaints or adverse events have been reported in China to date. Under the NMPA's regulatory framework, the company's required corrective actions include notifying all affected customers about the recall and emphasizing the critical importance of strictly adhering to the product's instruction manual during operation to ensure user safety.