Datex-Ohmeda recalls GE Healthcare Giraffe Incubator Carestation CS1 infant incubators with specific model numbers due to potential formaldehyde exposure during initial use. The risk is sensory irritation, not serious injury.
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.
Datex-Ohmeda is recalling GE Healthcare Giraffe Incubator Carestation CS1 infant incubators with 32 specific model numbers. The recall is due to a potential for higher levels of formaldehyde exposure during initial use, which could cause eye irritation. This risk decreases after about a week of use.
The incubators were manufactured with higher levels of airborne formaldehyde that could cause temporary eye irritation during initial use. This risk decreases significantly after about a week of use, as the formaldehyde off-gasses.
Parents or caregivers of infants using the recalled incubators. The risk is limited to temporary eye irritation from formaldehyde exposure during initial use, which decreases after about a week.
Check if your incubator has one of the 32 listed model numbers. The models are detailed in the recall notice, including specific serial numbers and UDI codes.
Run the incubator for about a week to allow formaldehyde to off-gas, reducing the risk of eye irritation.
No, the recall is for potential temporary eye irritation from formaldehyde exposure during initial use, which decreases after about a week of use. This is not a serious injury risk.
No, you can continue using it after running it for about a week to off-gas formaldehyde.
Check if your incubator has one of the 32 specific model numbers listed in the recall notice, including the serial numbers and UDI codes.
We’ve drafted a message you can send Datex-Ohmeda to request your refund or repair — edit it as you like.
Subject: Recall Z-0141-2025 — Datex-Ohmeda Datex-Ohmeda Hello, I own a Datex-Ohmeda that is covered by recall Z-0141-2025 from Datex-Ohmeda. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
