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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87445

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 26, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CAIRE DIAGNOSTICS INC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1284-2021
Recall number
Z-1284-2021
Initiated
February 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
CAIRE DIAGNOSTICS INC
Quantity
381 units (171 units U.S. and 210 units O.U.S.)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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.