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

Ethicon Endo-Surgery, LLC, through its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a Level 1 recall for its curved and straight endo-surgery staples and endoscopic curved endo-surgery staples. This critical recall, first reported on April 11, 2019, and updated on May 20, 2019, addresses manufacturing defects including uncut gaskets and poor staple formation. These issues significantly compromise the integrity of anastomosis sutures, posing a serious risk of postoperative anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock to patients.

The regulatory action falls under the National Medical Products Administration (NMPA) framework, identified by Index No. JGXX-2019-10351. The recall level was reclassified to Level 1 due to the severe potential health consequences. A total of 114,501 units were imported into China, with 15,854 units subsequently identified in the company's warehouse awaiting processing.

Required actions include immediate notification and confirmation from affected customers. All unused products within their expiration dates, whether held by customers or in company inventory, must be returned to the central warehouse. These items will then either be shipped back to the manufacturer, Ethicon Endo-Surgery, LLC, or destroyed on-site. All affected products within the company's warehouse have been isolated.