China NMPA Product Recall - Laparoscopic articular head linear cutting stapler and staple cartridge

Ethicon Endo-Surgery, LLC, through its responsible unit in China, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a global voluntary recall of its Laparoscopic Articular Linear Cutting Stapler and Staple Cartridge (trade name: ECHELON FLEX, model ECR60T) in May 2013. This action was prompted by the potential for staple cartridge damage during firing, which could lead to incomplete anastomosis line formation and insufficient tissue alignment, possibly requiring additional surgical intervention. This notice, published by China's National Medical Products Administration (NMPA) on June 17, 2013, highlights the regulatory oversight of medical devices. While the recall is global, it's important to note that the specific affected product models with expiration dates between May 2013 and March 2014 had not been marketed, imported, or sold within China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that its actions within China would be limited to reporting the recall event to the NMPA. No further in-country investigation, implementation plans, or recall reports would be submitted, as there were no units in the Chinese market to retrieve. The NMPA, for its part, instructed provincial Food and Drug Administrations to enhance supervision and management of such products.