The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1289-2025·Announced 2025-03-19

Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter

Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall meets the rubric criterion for Critical (5): FDA Class I. The manufacturing defect—tube diameter smaller than expected—creates risk of inadequate ventilation, hypoxia, and cardiopulmonary collapse during patient care.

Plain-English summary

Smiths Medical ASD, Inc. is recalling Portex Endotracheal Tubes under an FDA Class I recall. The recalled product includes multiple item codes (100/105, 100/111, 100/126, 100/127, and 100/141) distributed nationwide in the United States and worldwide.

Affected tubes have a smaller diameter than expected, which may result in inadequate ventilation to the patient. This manufacturing defect can cause hypoxia, underdose, or cardiopulmonary collapse.

The recall impacts endotracheal tubes distributed under specific lot numbers. Healthcare facilities should verify whether their inventory includes any affected lots.

The recalled product

Product
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
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Airway Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 100/105/025 UDI-DI 15019315018633
  • 100/105/030 UDI-DI 15019315018640

Distribution

Distributed nationwide across the United States.

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