Smiths Medical Issues Urgent Medical Device Correction for Endotracheal Tubes

Smiths Medical has issued an “Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected.”

When the device’s diameter is smaller than expected, it could “potentially result in inadequate ventilation to the patient [or] post-insertion of the endotracheal tube. In such situations, the patient may experience hypoxia, underdose, and/or cardiopulmonary collapse which may lead to death. To date, Smiths Medical has received eight (8) reports of serious injury that are potentially related to this issue.”

A letter was sent to impacted customers and distributors outlining risks and providing steps to determine whether their devices are affected. Affected products were “manufactured from 01 October 2019 to 03 October 2024 and distributed from 30 October 2019 to 16 December 2024.” The FDA has been notified of the action.