Smiths Medical ASD, Inc. recalls Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/03…

Recall date

February 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1289-2025

FDA classification

Class I

Brand / firm

Smiths Medical ASD, Inc.

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035