Z-2198-2025Class II

Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

Name: Z-2198-2025 Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Creator: Capnia Inc
Published: 2025-04-21
License: https://open.fda.gov/license/

Capnia Inc / initiated 2025-04-21 / Open, Classified / root cause: design

FDA source

Capnia Inc began a recall of Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor on 2025-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2198-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-21
Posted: 2025-07-29
Recalling firm: Capnia Inc
Product: Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Product code: CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Reason for recall: 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 tag: design
FDA 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 in commerce: 2160
Distribution: US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Product codes and lots: Monitor UDI-DI: 00858481006017. Lot (C20206): 231220

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2198-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29

Product code CCJ

K151107Class IICoSense ETCO MonitorCapnia, Inc. / cleared 2015-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)