# FDA recall Z-1289-2025

> **Smiths Medical ASD, Inc.** · Class I · device recall initiated 2025-02-13.

## 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

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1289-2025
- **Recalling firm:** Smiths Medical ASD, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-13
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2025

## Citation

> AI Analytics. FDA recall Z-1289-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1289-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*