CAIRE DIAGNOSTICS INC: Medical Device Recall in 2021 - (Recall #: Z-1284-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 26, 2021

Date Posted: March 31, 2021

Recall Number: Z-1284-2021

Event ID: 87445

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.

Status: Terminated

Product Quantity: 381 units (171 units U.S. and 210 units O.U.S.)

Code Information:

All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated