FDA recall announcements and official FDA website

FDA Classifies Smiths Medical Tracheostomy Tubes Recall as Most Serious, 35 Injuries and 2 Deaths Reported

Sep 19, 2024, 05:40 PM

The U.S. Food and Drug Administration (FDA) has classified the recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes made by Smiths Medical, a unit of ICU Medical, as the most serious type. This classification indicates that the defect could cause severe injury or death. The recall, which involves the removal of these tubes due to a manufacturing defect, has been linked to 35 reported injuries and two deaths. The FDA's action underscores the critical nature of the manufacturing defect in these medical devices.