Formaldehyde Emissions Result in Datex-Ohmeda Recall of Air Compressors

GE HealthCare subsidiary, Datex-Ohmeda’s recall of EVair and Jun-air compressors has been deemed Class I by the FDA due to potentially elevated levels of formaldehyde emissions.

The EVair and Jun-air compressors are optional ventilator accessories that provide an alternative source of air flow where wall air is unavailable. The potential for elevated levels of formaldehyde can occur at high temperature and low gas flow conditions when used with the Carescape R860 or Engstrom Carestation or Pro ventilators.

Use of the affected air compressors may cause serious adverse health consequences, including airway irritation or inflammation that could lead to airway hyperresponsiveness in newborns or infants, the agency said. There have been no reported injuries or reports of death associated with this issue. The recall is a correction, not a product recall. 

Read the FDA recall announcement here.

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