Covidien Roticulator Surgical Stapler Recall Due To Contamination Risk

Covidien has issued a recall of Roticulator single-use surgical staplers, due to potential sterility issues that may pose an infection risk for patients. 

The Covidien Roticulator stapler recall (PDF) was announced on May 15, affecting 58 lots of the staplers, which are used to close wounds and surgical incisions.

According to the manufacturer, the sterility barrier for the surgical staplers was compromised, meaning that they may be contaminated and could increase the risk that patients undergoing surgery develop an infection. Covidien indicates that it is working in cooperation with the FDA in the United States.

Five stapler designs are impacted by the recall: The Roticulator 55-3.5, 55-4.8, 30-3.5, 30-4.8 and 30-V3 single-use staplers. Some of the surgical staplers have been used in Covidien Best Practice Kits and these kits should be checked for staplers of the affected lots. A full list of affected lots is located in the recall notice.

Covidien is asking all of its customers to return staplers affected by the recall. The company has recommended that its customers contact their Covidien representative if they have any questions.

This is the second major surgical stapler recall for the company this year. In January the FDA announced a Covidien Duet TRS recall following reports of three deaths and at least 13 serious injuries. That stapler was reportedly causing surgical errors by damaging surrounding organs and other vital body parts when it was used in the thorax.