FDA Device recall Z-2198-2025
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor by Capnia, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2198-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-21 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Capnia |
| Distribution | US |
Product
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Reason
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.
Identifiers
| code_info | Monitor UDI-DI: 00858481006017. Lot (C20206): 231220 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2198-2025%22
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