# FDA recall Z-2401-2021

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2021-08-04.

## Product

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

## Reason for recall

The incorrect device is contained in the package.

## Distribution

International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.

## Key facts

- **Recall number:** Z-2401-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-04
- **Report date:** 2021-09-08
- **Termination date:** 2025-03-11

- **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-2401-2021

## Citation

> AI Analytics. FDA recall Z-2401-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2401-2021. Source: US FDA. Licensed CC0.

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