FDA Medical Device Recalls (openFDA)
Capnia Inc: Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
- Recall number
- Z-2198-2025
- Recalling firm
- Capnia Inc
- Product
- Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
- Status
- Open, Classified
- Initiated
- 2025-04-21
- Posted
- 2025-07-29
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- 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
- Quantity
- 2160
- Distribution
- US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
- Lot, serial or model codes
- Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
- 510(k) numbers
- ["K151107"]
- PMA numbers
- not on file
- Product code
- CCJ
- Firm FEI
- 3008614998
- Firm city
- Foster City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28