The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0775-2024·Announced 2024-02-07

FDA recalls EVair 03 compressor models for elevated formaldehyde levels

FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which warrants a minimum severity score of 4 per the classification rules. No deaths or reported illnesses have been documented; the elevated formaldehyde levels were detected only in preliminary testing under non-typical clinical conditions.

Plain-English summary

GE HealthCare has recalled the EVair 03 and Jun-air medical air compressors (models 1609000 and 1609002) in response to elevated formaldehyde levels detected during testing. Twelve units of these compressors are affected worldwide.

The compressors can produce elevated levels of formaldehyde when used with specific ventilators: the CARESCAPE R860 or Engström Carestation/Pro models. These elevated levels were observed during preliminary laboratory testing conducted at elevated room temperature (40°C / 104°F) and at minimal flow conditions (2 L/min), using only gas from the compressor without supplemental oxygen. GE HealthCare notes that these test conditions do not represent typical clinical use conditions but is taking this recall action to reduce potential patient exposure.

Patients and healthcare facilities using these air compressor models should verify their equipment serial numbers. The recalled serial numbers are: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, and CBCU00559.

The recalled product

Product
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Manufacturer
Datex-Ohmeda, Inc.
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
12

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 (13)

  • UDI/DI ********
  • Serial Numbers: CBCS01269
  • CBCT02328
  • CBCT03050
  • CBCT02306
  • CBCT02301
  • CBCT02303
  • CBCT02302
  • CBCT02088
  • CBCT02309
  • CBCT02304
  • CBCU00717
  • CBCU00559

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 →

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