BD Recalls Esophagogastric Tubes After Injuries and Death

BD has issued a Class I recall of five models of esophagogastric balloon tamponade tubes used to control bleeding in the esophagus and stomach, following reports of two serious injuries and one death. The recall updates the instructions for use to address difficulties removing plastic plugs from the tubes’ lumens, which can delay treatment or damage the device.

Users are now advised to remove plugs before patient use by inserting a hemostat jaw between the plug and tube, rotating it to loosen, then removing the plug. BD recommends storing a hemostat with the tubes.

The recall, managed by BD’s C.R. Bard subsidiary, was announced by the FDA on May 20. The devices remain on the market with updated instructions to improve safety and effectiveness.

03-06-2025