CAIRE DIAGNOSTICS INC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
CAIRE DIAGNOSTICS INC
Lot Codes / Batch Numbers
All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).
Products Sold
All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).
CAIRE DIAGNOSTICS INC is recalling CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to due to Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Between 02/21-26/2021, the firm contacted its customers via email/phone and Zoom to inform them that two calibration errors were noted for the Asthma Monitor regarding, 1) drift in calibration gases and 2) a software error that may cause a high reading indicating that a therapeutic action should be taken. This may result in prescription of unneeded medication to the patient. On 02/26/2021, the firm sent a follow-up "Urgent - Medical Device Recall" Notification further instructing the customers to: 1. Discontinue use of the device. Make all personnel who use it aware of this recall. 2. Contact Recalling Firm or their distributor. Contact at +1-888-609-4839 or customerservice.cdx@caireinc.com. The Recalling Firm will arrange for shipment of the device back to the factory for a software update and re-calibration. If the customer purchased the affected products from a distributor, they should contact them to arrange shipment. 3. Distributors: Please cease distribution of the device and contact the Recalling Firm to arrange for return of their existing inventory for a software update and re-calibration, or device replacement. Distributors should immediately forward the Recall Notification to all affected customers and request that they comply with the recall process. Additional questions or assistance contact - +1-888-609-4839 or customerservice.cdx@caireinc.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026