China NMPA Product Recall - Curved and straight endoscopic anastomotic devices, endoscopic curved endoscopic anastomotic device

On April 11, 2019, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its curved and straight endoscopic anastomosing devices. This action was reported to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration Medical Device Registry. The recall specifically addresses certain models of the curved endoscopic anastomosing device due to identified manufacturing issues. The primary concerns identified were uncut gaskets and suboptimal staple formation. These defects have the potential to compromise the integrity of the anastomosis suture during medical procedures. The affected products include devices with registration certificate numbers 20152652249 and 20152650241. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. provided a "Medical Device Recall Event Report Form" containing detailed information on the specific models, specifications, and batches implicated in this recall, ensuring transparency and facilitating the retrieval of affected units from the market. This proactive measure aims to safeguard patient safety and ensure the reliability of their medical devices.