EVair air compressor — Class I medical device recall Z-0774-2024
Ongoing recall by Datex-Ohmeda, Inc., reported 2024-02-07. GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optiona
| Recall number | Z-0774-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datex-Ohmeda, Inc., Madison, WI, United States |
| Recall initiated | 2023-12-29 |
| Classified | 2024-01-30 |
| Reported by FDA | 2024-02-07 |
| Quantity | 4,032 units |
| Serial numbers | CBRT00101, CBRT00110, CBRT00111, CBRT00113, CBRT00147, CBRT00148, CBRT00149, CBRT00151, CBRT00153, CBRT00156, CBRT00246, CBRT00247, CBRT00297, CBRT00306, CBRT00307, CBRT00308, CBRT00309, CBRT00364, CBRT00365, CBRT00366, CBRT00367, CBRT00368, CBRT00369, CBRT00370, CBRT00380 and 475 more |
| Model numbers | M1230847, M1230849 |
Product
EVair air compressor, model numbers: M1230849 and M1230847
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.