Precision Sampling Set (Capnia) – Contamination Risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Brand
Capnia Inc
Lot Codes / Batch Numbers
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Products Sold
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Capnia Inc is recalling Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor due to Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026