China NMPA Product Recall - Puncture device (product name: ENDOPATH XCEL)

Johnson & Johnson Medical Devices Co., Ltd., on behalf of manufacturer Ethicon Endo-Surgery, LLC, initiated a global recall for their ENDOPATH® XCEL T™ OPTIVIEW™ Endoscopic Instruments. This recall, reported on October 21, 2010, and documented by the National Medical Products Administration (NMPA) on November 3, 2010, addresses a critical product defect. The primary issue identified was an increase in reports of air leaks during laparoscopic surgical procedures. Such leaks can result in a loss of pneumoperitoneum, potentially necessitating a conversion from minimally invasive laparoscopic surgery to a more invasive open procedure, thus impacting patient safety. The recall applies to specific models and batch numbers, with 127 affected units either manufactured or imported into China. Under the NMPA's regulatory framework, Johnson & Johnson's required corrective action involves notifying all users of the affected products about the issue and the necessary recall procedures to mitigate risks.