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

Class I - Dangerous

🏥 Medical Devices Recalled: December 29, 2023 Datex-Ohmeda Other Medical Devices

What Should You Do?

Check if you have this product:
UDI/DI ********, Serial Numbers: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, CBCU00559
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Datex-Ohmeda, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0775-2024

Related Recalls

GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

DATEX--OHMEDA

Class I - Dangerous

Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

Jun 6, 2023 Other Medical Devices View Details →

GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15) 2082844-001-01122391; 16) 2082844-001-01128579; 17) 2082844-001-01128725; 18) 2082844-001-01131573; 19) 2082844-001-01140642; 20) 2082844-001-01165870; 21) 2082844-001-100397; 22) 2082844-001-100676; 23) 2082844-001-100740; 24) 2082844-001-100743; 25) 2082844-001-100744; 26) 2082844-001-101075; 27) 2082844-001-101149; 28) 2082844-001-101199; 29) 2082844-001-101202; 30) 2082844-001-101203; 31) 2082844-001-101356; 32) 2082844-001-101366; 33) 2082844-001-101656; 34) 2082844-001-102136; 35) 2082844-001-102589; 36) 2082844-001-102858; 37) 2082844-001-526493; 38) 2082844-001-533346; 39) 2082844-001-570904; 40) 2082844-001-615985; 41) 2082844-001-616544; 42) 2082844-001-674814; 43) 2082844-001-701655; 44) 2082844-001-704407; 45) 2082844-001-709042; 46) 2082844-001-857748; 47) 2082844-001-888278; 48) 2082844-001-941288; 49) 2082844-001-965539; 50) 2082844-001-978713; 51) 2082844-001-982099; 52) 2082844-001-982310; 53) 2082844-001-982985; 54) 2082844-001-982988; 55) 2082844-001-983509; 56) 2082844-001-983643; 57) 2082844-001-983679; 58) 2082844-001-984096; 59) 2082844-001-984948; 60) 2082844-001-987480; 61) 2082844-001-987855; 62) 2082844-001-993967; 63) 2082844-001-994441; 64) 2082844-001-995782; 65) 2082844-001-998377; Radiant infant warmer

DATEX--OHMEDA

Class I - Dangerous

Jun 6, 2023 Other Medical Devices View Details →

Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Datex-Ohmeda

Class I - Dangerous

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Jul 12, 2024 Patient Monitors Nationwide View Details →