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 System, as publicly reported by the National Medical Products Administration (NMPA) on February 21, 2017. The core safety concern revolves around a potential malfunction where, following an external power outage, the system's door lock may temporarily loosen for 20 seconds during the restart process. This flaw poses a risk of user exposure to potentially injurious concentrations of hydrogen peroxide. The company's action to recall these products falls under a Level II classification, indicating that the use of, or exposure to, the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Detailed information concerning the precise models, specifications, and batch numbers of the implicated devices is available in the accompanying "Medical Device Recall Event Report Form." This voluntary recall reflects the company's commitment to product safety and compliance with the NMPA's regulatory standards for medical devices.