EVair Air Compressors Recalled for Elevated Formaldehyde Emissions
EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which requires a minimum Severe (4) score per the rubric rules. The preliminary testing conditions were non-typical, and the source does not report any adverse clinical events.
Plain-English summary
GE HealthCare is recalling EVair air compressors (models M1230849 and M1230847) made by Datex-Ohmeda, Inc., which are used with CARESCAPE R860 and Engström Carestation/Pro ventilators in medical facilities worldwide. Approximately 4,032 units have been distributed globally.
During preliminary testing at elevated room temperature (40°C / 104°F) and minimum gas flow conditions (2 L/min), elevated formaldehyde levels were detected. GE HealthCare notes these test conditions do not represent typical clinical use. The company is investigating the root cause and taking this precautionary action to reduce potential patient exposure.
Healthcare facilities using these compressors should contact GE HealthCare or Datex-Ohmeda for information about their specific units and guidance on inspection or continued use.
The recalled product
- Product
- EVair air compressor, model numbers: M1230849 and M1230847
- Manufacturer
- Datex-Ohmeda, Inc.
- Hazard
- formaldehyde-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 010084068210234621
- Serial Numbers: CBRW00622
- CBRW00639
- CBRW00630
- CBRW00643
- CBRW00625
- CBRW00623
- CBRX04576
- CBRX04581
- CBRX04579
- CBRX04577
- CBRX04578
- CBRY00721
- CBRY00708
- CBRY00706
- CBRY00688
- CBRY00278
- CBRY02044
- CBRY02051
- CBRY02043
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27