Foster City, CA, United States
Capnia Inc recalls
1 recall recorded since 2018, most recently on 21 April 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 April 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2198-2025
- Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.