Class II — Capnia Inc
| Recalling firm | Capnia, Inc. |
|---|---|
| Registered facility | CAPNIA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor |
| Quantity | 2160 |
| Distribution | US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA. |
| Initiated | 2025-04-21 |
| Classified | 2025-07-29 |
| Recall number | Z-2198-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Capnia Inc (Z-2198-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97184/
Alerts for Capnia, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.