FDA Medical Device Recalls (openFDA)
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 number
- Z-1284-2021
- Recalling firm
- CAIRE DIAGNOSTICS INC
- 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.
- Status
- Terminated
- Initiated
- 2021-02-26
- Posted
- not on file
- Terminated
- 2023-03-24
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 381 units (171 units U.S. and 210 units O.U.S.)
- 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.
- Lot, serial or model codes
- All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).
- 510(k) numbers
- ["K182874"]
- PMA numbers
- not on file
- Product code
- MXA
- Firm FEI
- 3013216353
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28