China NMPA Product Recall - Anti-bedsore air mattress

Stryker Medical, through its subsidiary Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class III recall of its anti-decubitus air mattresses (Registration Certificate No.: 20171077). This recall, announced on November 30, 2020, is a proactive measure taken by the manufacturer in response to an issue identified as incorrect labeling on specific models and batches of the product. The National Medical Products Administration (NMPA) of China is the regulatory body overseeing this action. The NMPA document, bearing index number JGXX-2020-10659, formally reports this event. The main issue centers on administrative non-conformity rather than immediate safety hazards, categorized as a Class III recall, which typically addresses situations where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Detailed information regarding the precise models, specifications, and affected product batches is contained within an accompanying "Medical Device Recall Event Report Form," which was referenced but not provided in the public announcement. This action underscores the company's commitment to compliance with regulatory standards for medical devices.