# FDA recall Z-2198-2025

> **Capnia Inc** · Class II · device recall initiated 2025-04-21.

## Product

Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

## Reason for recall

Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

## Distribution

US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.

## Key facts

- **Recall number:** Z-2198-2025
- **Recalling firm:** Capnia Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-21
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foster City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2025

## Citation

> AI Analytics. FDA recall Z-2198-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2198-2025. Source: US FDA. Licensed CC0.

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