# FDA recall Z-0529-2025

> **Smiths Medical ASD, Inc.** · Class II · device recall initiated 2024-10-28.

## Product

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x  70cm, REF 14-504-76

## Reason for recall

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube.  This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0529-2025
- **Recalling firm:** Smiths Medical ASD, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-28
- **Report date:** 2024-12-04

- **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-0529-2025

## Citation

> AI Analytics. FDA recall Z-0529-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0529-2025. Source: US FDA. Licensed CC0.

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