CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Precision Sampling Set recalled by Capnia
Capnia is recalling Precision Sampling Set, distributed nationwide in the US. The recall was initiated on 21 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2198-2025
- FDA event ID
- 97184
- Recalling firm
- Capnia, Foster City, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2025
- FDA classified
- 29 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Patient Monitors
Timeline
| 21 Apr 2025 | Recall initiated by company | |
| 29 Jul 2025 | Classified by FDA | +99 days |
| 6 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Where it was distributed
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Where was it sold?
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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