Recently, Johnson & Johnson (Shanghai) Medical Device Co., Ltd. reported to the regulatory authorities that its manufacturer, Ethicon Endo-Surgery, LLC (Ethicon Endo - Surgery, LLC) Proactively initiated a recall for specific products under its brand. The products subject to this recall are electric endoscopic linear vascular cutting and stapling devices and staple cartridges.The specific model isECHELONTM Flex Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH ECHELONTM Vascular White Reload for Advanced Placement Tip, Registration Certificate No. is 国械注进20163012981, and the recall level was classified as a Level 1 recall.This recall involves67272Items, products sold in China involve56560Item.

It is understood that the trigger for this recall was an upward trend in complaints about specific batches of the product.After detailed investigation and analysis, the issue focused on the safety locking mechanism of the device.During the surgical procedure, the safety locking mechanism is crucial for ensuring the stability and precise operation of the instruments. If this mechanism malfunctions, it may cause the stapler to fail in performing its functions at critical moments, such as deviations during cutting and anastomosing blood vessels. This not only affects the surgical outcome but also poses severe health risks to the patient, including complications like bleeding and vascular damage, which could even endanger the patient’s life.

Ethicon Endo-Surgery (China) Co., Ltd. takes this issue very seriously. To clearly emphasize the solution and its importance regarding the safety lock of instruments to the medical industry, the company has decided to initiate a voluntary recall.