The Recall Desk
SevereFDA (Devices)·Z-0774-2024·Announced 2024-02-07

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.
Category
Medical Device — Ventilator Components
Hazard
Affected units
4,032

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.

Part of a larger recall action

This product is one of 3 recalled by Datex-Ohmeda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Datex-Ohmeda, Inc.

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Same hazard · formaldehyde exposure

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