Capnia Inc: Medical Device Recall in 2025 - (Recall #: Z-2198-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 21, 2025

Date Posted: August 6, 2025

Recall Number: Z-2198-2025

Event ID: 97184

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.

Status: Ongoing

Product Quantity: 2160

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.

Voluntary or Mandated:

Voluntary: Firm initiated