China NMPA Product Recall - Nimbus Professional STD Medical Anti-Decubitus Mattress

On April 19, 2021, Anju Medical Devices (Suzhou) Co., Ltd. initiated a Class III voluntary recall for its Nimbus Professional STD medical anti-decubitus mattress. This action was taken under the oversight of the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration. The primary concern identified was a very low probability of internal tube rupture and air leakage, leading to mattress inflation, particularly under conditions of prolonged use, improper operation, or inadequate maintenance. Although no health hazards have been reported to date, the company acknowledged a potential, albeit minimal, risk. To address this issue, Anju Medical Devices has implemented several corrective measures. The company issued comprehensive recall notices to all affected medical device distributors and end-users. Additionally, the manufacturer provided direct maintenance services for customers' mattresses and secured customer acknowledgment of these actions. The recall impacts 12,781 units globally, with 192 units specifically in China. The affected products were distributed across various regions including Europe, Asia, Oceania, Africa, and the Americas. This voluntary recall demonstrates the company's commitment to product safety and quality assurance.