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

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class I recall of its curved and straight endo-stabilizers and endoscopic curved endo-stabilizers. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, was first published on April 11, 2019, and updated on May 7, 2019, elevating the recall to Level 1, signifying the highest potential for severe health consequences. The core issue, confirmed by Ethicon Endo-Surgery, LLC, involves manufacturing defects such as uncut gaskets and poor staple formation in specific product batches. These critical flaws compromise the integrity of the anastomosis line, leading to significant postoperative risks. Patients may experience anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock if these device-related problems are not detected or adequately managed. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is actively working to remove the affected devices, identified by Registration Certificate Nos. 20152652249 and 20152650241, from the market to ensure patient safety. Further details on affected models and batches are available in the accompanying recall event report form.