China NMPA Product Recall - Tissue grasping forceps for endoscopic surgery

Covidien LLC initiated a voluntary Class II recall of its Tissue Grasping Forceps for Endoscopic Surgery, as reported to the National Medical Products Administration (NMPA) on March 13, 2019, and published on March 21, 2019. The recall stems from a critical inconsistency identified during a review of manufacturing records: specific batches of the forceps, certified under National Medical Device Registration Certificate 20152222924, were not sterilized according to their approved method. The primary issue was that products intended for V-ray sterilization were sometimes subjected to re-sterilization using ethylene oxide (EO) or additional V-ray exposure. While EO re-sterilization did not compromise product performance, it deviated from the stated labeling. Crucially, repeated V-ray sterilization increased the potential for product failure and component decomposition during use, which could lead to surgical delays. Despite these deviations, all recalled products maintained good sterility, and Covidien LLC confirmed no global complaints related to these affected batches. The recall specifically targeted models 174317 and 173030 across various lot numbers, impacting markets in the United States, Canada, Japan, Europe, and Latin America. Notably, no affected products were sold in China, thus precluding the need for further corrective actions within that country. This recall highlights the importance of strict adherence to approved manufacturing and sterilization protocols in medical device production.