China NMPA Product Recall - Laparoscopic linear stapler (trade name: ENDOPATH®)

The National Medical Products Administration (NMPA) in China, referencing Index No. JGXX-2012-10014 and a January 19, 2012, publication, reported a voluntary global recall initiated by Ethicon Endo-Surgery, LLC. The recall, handled in China by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., pertains to specific models (CTS45, CTS45NK) of the ENDOPATH® laparoscopic linear anastomosis device. The core issue identified was potential damage to the product's blister packaging, which could compromise the instrument's sterility. While this recall was global, the manufacturer confirmed that the affected batches were neither imported into nor sold within the Chinese market. Consequently, the company indicated that specific corrective actions for China were "Not Applicable." However, the NMPA proactively directed provincial and municipal food and drug administrations to enhance their oversight and management of similar medical devices to maintain public safety, despite the product not entering the local supply chain.