The Recall Desk

Manufacturer

CAIRE DIAGNOSTICS INC

1 recall in our database name CAIRE DIAGNOSTICS INC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2021-03-31

Of the 1 recalls from CAIRE DIAGNOSTICS INC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • SevereFDA (Devices)·Z-1284-2021·2021-03-31

    Caire Diagnostics Recalls FenomPro Devices Due to Erroneous High FeNO Readings

    Caire Diagnostics is recalling FenomPro devices because calibration drift and software errors may cause erroneously high FeNO readings, potentially leading to premature discontinuation of asthma treatment.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide