CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** — Class II medical device recall Z-1284-2021
Terminated recall by CAIRE DIAGNOSTICS INC, reported 2021-03-31, distributed nationwide. Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment a
| Recall number | Z-1284-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CAIRE DIAGNOSTICS INC, Pleasanton, CA, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-03-19 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2023-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, DE, ES, FR, GR, HK, HR, IN, PH |
| Reason classes | software |
| Serial numbers | 100107, 100651 |
| Model numbers | 900-0001 |
Product
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
Reason for recall
Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1284-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.