FDAClass IIAugust 6, 2025

Precision Sampling Set recall

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

Why was Precision Sampling Set 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 I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Monitor UDI-DI: 00858481006017. Lot (C20206): 231220

Product
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Recalling firm
Capnia Inc
Quantity
2160
Distribution
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Recall date
August 6, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls