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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Capnia Precision Sampling Set Nasal Cannulas Recalled for Chemical Residue

Agency Publication Date: July 29, 2025
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Summary

Capnia Inc is recalling 2,160 units of its Precision Sampling Set (REF: C20206) used with the CoSense End-Tidal Carbon Monoxide Monitor. The devices may contain residual carbon monoxide and volatile organic compounds because the carbon filters were not properly aired out before the units were sealed. While no injuries have been reported, this chemical residue can cause inaccurately high test results during patient evaluations.

Risk

The chemical residue in the nasal cannula can lead to higher than expected carbon monoxide scores during clinical evaluations. This could result in incorrect medical assessments or improper treatment decisions based on flawed data.

What You Should Do

  1. This recall affects the Capnia Precision Sampling Set (REF: C20206) used with the CoSense End-Tidal Carbon Monoxide Monitor, specifically units from Lot 231220.
  2. Identify the affected products by checking the packaging for REF: C20206, Lot 231220, and UDI-DI 00858481006017.
  3. Stop using the recalled sampling sets immediately and remove them from clinical use.
  4. Contact Capnia Inc or your medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have further questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Precision Sampling Set for use with the CoSense End-Tidal Carbon Monoxide Monitor
Model / REF:
C20206
Lot Numbers:
231220
UDI:
00858481006017

Used with CoSense End-Tidal Carbon Monoxide Monitor.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97184
Status: Active
Manufacturer: Capnia Inc
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 2160
Distributed To: Pennsylvania, Utah, Texas, Florida, Massachusetts, Iowa

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.