# FDA recall Z-1405-2025

> **Smiths Medical ASD, Inc.** · Class II · device recall initiated 2025-02-14.

## Product

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

## Reason for recall

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

## Distribution

US Nationwide distribution. International distribution pending.

## Key facts

- **Recall number:** Z-1405-2025
- **Recalling firm:** Smiths Medical ASD, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-14
- **Report date:** 2025-03-26

- **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-1405-2025

## Citation

> AI Analytics. FDA recall Z-1405-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1405-2025. Source: US FDA. Licensed CC0.

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