Capnia Inc recalls Precision Sampling Set

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.

Starting on 4/21/2025 Product Advisory and Voluntary Field Action emails were sent to customers who were told affected devices would be replaced. Customers with questions could contact the firm at 904-588-2986

• FDA enforcement recordOfficial FDA database entry for Z-2198-2025
• FDA 510(k) clearance · K151107The device's official FDA premarket clearance record
• FDA device classification · CCJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.1430The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Capnia IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.