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

Ethicon Endo-Surgery, LLC, in conjunction with its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a recall for its curved and straight endoscopic anastomosing devices. The initial recall, reported to the National Medical Products Administration (NMPA) on April 11, 2019, was escalated from a Level II to a critical Level I on May 20, 2019, as detailed in the NMPA document JGXX-2019-10352 published June 3, 2019. The key issues identified were manufacturing defects, specifically uncut gaskets and poor staple formation, which compromise the integrity of the surgical anastomosis. These defects present significant patient risks, including postoperative anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock. The required corrective actions involve promptly notifying all affected customers and obtaining confirmation. Unused, unexpired products from both company inventory and customer holdings are to be returned to the warehouse for subsequent shipment back to the manufacturer or on-site destruction. A total of 114,501 units were imported into China, with 15,854 units currently isolated in inventory.