Datex-Ohmeda recalls EVair air compressors (model M1230849 and M1230847) due to elevated formaldehyde levels observed in testing at high temperatures and low flow conditions. The risk is not typical clinical use but could affect patient exposure.
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.
Datex-Ohmeda is recalling EVair air compressors with model numbers M1230849 and M1230847 because preliminary testing showed elevated formaldehyde levels under specific conditions. This risk is not typical of normal clinical use but could occur in certain environments.
Elevated formaldehyde levels were observed in preliminary testing at 40°C (104°F) with the lowest possible flow rate of 2 L/min. This scenario is not typical of normal clinical use but could happen in high-temperature environments with minimal airflow.
Healthcare facilities using these specific EVair air compressors with the listed model numbers and serial codes are most at risk. Patients using the compressors in clinical settings may be exposed if the conditions described in the recall occur.
Check if your EVair air compressor has model numbers M1230849 or M1230847 and the listed serial numbers (e.g., CBRW00622, CBRW00639, etc.).
Verify if your EVair air compressor has model numbers M1230849 or M1230847 and the listed serial numbers.
No, the elevated formaldehyde levels were observed only under specific test conditions (40°C, 2 L/min flow) that are not typical of normal clinical use. The risk is not expected to occur in regular healthcare settings.
Check the model numbers (M1230849 or M1230847) and serial numbers (e.g., CBRW00622, CBRW00639) listed in the recall notice.
The recall does not specify a remedy, so you should check with Datex-Ohmeda for further instructions if you have the affected product.
We’ve drafted a message you can send Datex-Ohmeda to request your refund or repair — edit it as you like.
Subject: Recall Z-0774-2024 — Datex-Ohmeda Datex-Ohmeda Hello, I own a Datex-Ohmeda that is covered by recall Z-0774-2024 from Datex-Ohmeda. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
