Datex-Ohmeda, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0775-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

Product Classification:

Class I

Date Initiated: December 29, 2023

Date Posted: February 7, 2024

Recall Number: Z-0775-2024

Event ID: 93715

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.

Status: Ongoing

Product Quantity: 12 units

Code Information:

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

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated