FDA Medical devices recall ·
Precision Sampling Set recall
- Recall number
- Z-2198-2025
- Date
- (initiated April 21, 2025)
- Company / brand
- Capnia Inc
1101 Chess Dr, Foster City, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2160
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Distribution
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
States: Florida Iowa Massachusetts Pennsylvania Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2198-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.