Precision Sampling Set, REF: C20206 for use with the… recallZ-2198-2025 · Capnia Inc · initiated Apr 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Capnia Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-2198-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 21, 2025
- Posted by the FDA
- Jul 29, 2025
- Recalling firm
- Capnia Inc
- Quantity
- 2160
- Product code
- CCJ
- FDA submissions
- K151107
- Distribution
- US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Product description
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Code information (models, lots, serial numbers)
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CoSense ETCO Monitor C20112Capnia, INC. · Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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