Use cautionMedical device recall · FDA · Published February 26, 2021
CAIRE FenomPro device may give false high FeNO readings; stop using if for asthma
CAIRE Diagnostics recalls FenomPro devices sold before Feb 2021 due to inaccurate FeNO readings that could lead to improper asthma management. Affected units have serial numbers 100107-100651.
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.
Take action
Contact the company
📍Recalling firmCAIRE DIAGNOSTICS INC7020 Koll Center Pkwy · Pleasanton, CA 94566-3103
✎ GovInfoNow plain-language explainer
CAIRE Diagnostics recalls FenomPro devices sold before February 23, 2021 that may give falsely high FeNO readings. This could cause asthma treatment to be stopped prematurely or disease to worsen. The issue comes from calibration drift and software errors in the device. Read more at govinfonow.com/recall/63217-caire-fenompro-device-may-give-false-high-feno-readings-stop.
“CAIRE FenomPro device may give false high FeNO readings; stop using if for asthma.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63217-caire-fenompro-device-may-give-false-high-feno-readings-stop. Based on FDA recall #Z-1284-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1284-2021%22&limit=1).
The FDA announced on Feb. 26, 2021, that CAIRE Diagnostics Inc. is recalling its FenomPro portable device due to erroneous high fractional exhaled nitric oxide readings. The agency said the error stems from calibration gas drift and software issues.
How to tell if you have it
Brand: CAIRE Diagnostics
Product: FenomPro
REF: 900-0001
Serial numbers: 100107 to 100651
Units affected: 381 (171 in U.S., 210 overseas)
The hazard
The device may produce erroneously high FeNO levels, which could lead to premature discontinuation of effective asthma treatment and persistent underlying disease. The FDA cited two causes for these inaccurate readings: drift in the calibration gases and a software error.
Context
GovInfoNow's records show other recent recalls of similar medical devices include the Philips Cardiac Workstation 5000 (2026-07-01) and the Philips Cardiac Workstation 7000 (2026-07-01), both involving inaccurate heart rate data risks.
How to tell if you have this one
Check for serial numbers between 100107 and 100651. The device was sold before February 23, 2021. It measures fractional exhaled nitric oxide for asthma monitoring.
Brand
CAIRE Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for serial numbers between 100107 and 100651 on the device.
Stop Using Device
If you have an affected device, stop using it immediately to avoid inaccurate asthma treatment readings.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, TX, and WI. In the countries of Belgium, Canada, Croatia/Hrvatska, France, Germany, Greece, Hong Kong, India, Philippines, Spain, Spain and Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
No, the device may give inaccurate readings that could affect asthma treatment. It should not be used for critical care, emergency care, or anesthesiology.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1284-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1284-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.