Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EVair 03 (Jun-air) air compressor Recalled by Datex-Ohmeda, Inc. Due to GE HealthCare has become aware of elevated levels...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datex-Ohmeda, Inc. directly.
Affected Products
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Quantity: 12 units
Why Was This Recalled?
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
Where Was This Sold?
Worldwide
About Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report