Problems with Giraffe OmniBed Carestation Could Lead to Infant Injuries and Deaths, FDA Warns

Due to the risk of formaldehyde exposure, healthcare providers have been instructed to run the incubators for several weeks before use.

Federal regulators warn that certain GE infant incubators should be considered a risk of serious injury or death, due to their potential release of toxic formaldehyde fumes.

On December 6, the U.S. Food and Drug Administration (FDA) announced that a recent correction notice issued for the products by GE Healthcare should be considered a Class I Giraffe Omnibed Carestation and Incubator recall, which means that the agency believes that the problems could result in serious injury or death for newborns.

The Giraffe Omnibed and Giraffe Omnibed CareStation are intended for short-term use, providing controlled incubation or warming for premature or ill babies. These products can function as either an incubator or a warmer, and they can switch between the two modes.

The FDA and GE Healthcare first warned about problems with formaldehyde releases linked to the Giraffe Omnibed incubators in February 2023, announcing corrections and recalls for several brands of incubators over the last two years. The manufacturer then announced corrections to the instructions provided with the incubators in October 2023, which the FDA has now classified as a Giraffe Omnibed recall.

Updated GE Incubator Formaldehyde Instructions

Late last year, the FDA issued the new use instructions for healthcare providers about how to safely use the Giraffe Omnibed Carestations and Incubators. The update was issued after concerns the devices exposed infants to dangerous emissions of formaldehyde and other toxic chemicals.

The use instructions detail steps doctors should take to prevent formaldehyde exposure to infants using the products, who are usually less than four weeks old.

The FDA warns that neonates suffering from high levels of formaldehyde exposures could suffer serious health consequences, including neurological impairment, respiratory problems such as asthma, decreased lung function, inflammation, and irritation, as well as nasal, mouth, or throat cancer.

The updated instructions call for doctors to run Giraffe Omnibed Incubators and Carestations received before September 5, 2023 for several weeks prior to use. The devices should be run on maximum heat and humidity with the portholes and bedside panels closed, according to the instructions.

So far, there have been no reports of injuries or deaths linked to the use of the incubators or carestations.

This isn’t the only product quality issue involving GE Healthcare Giraffe Omnibed Incubators or Carestations. In October 2024, the FDA updated the instructions for Giraffe Omnibed and Giraffe Omnibed CareStations because improperly tightened screws on the devices could allow the heater doors to detach and seriously injure newborn infants during use.

The updated recall involves Giraffe Omnibed Carestation CS1 and Giraffe Incubator Carestation CS1 with unique device identifier codes: 00840682116862 and 00840682116855.

Customers with questions about the recall should contact GE HealthCare at 800-437-1171. Health side effects and injuries should be reported to the FDA’s MedWatch Adverse Event Reporting Program.