Covidien LLC Voluntarily Recalls Signia Small Diameter Reloads for Endoscopic Stapling Devices Due to Manufacturing Defect

Source: National Medical Products Administration website

Covidien Healthcare International Trading (Shanghai) Co., Ltd. reported that due to internal manufacturing issues in the shell tube pressing process during production, Covidien LLC, the manufacturer, is voluntarily recalling its single-use laparoscopic pre-installed chip stapler cartridges, Signia Small Diameter Reloads (China Medical Device Registration No. 20233010130). The recall level is classified as a Level III recall. Detailed information regarding the models, specifications, and batches of the affected products can be found in the "Medical Device Recall Event Report."