Datex-Ohmeda recalls 52 models of Giraffe Omnibed Carestation CS1 infant incubators due to potential formaldehyde exposure during initial use. The risk is sensory irritation, which is the most sensitive effect at low concentrations. Affected units were notified in June 2023 to run for a week to off-gas formaldehyde.
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 52 specific models of their Giraffe Omnibed Carestation CS1 infant incubators because older manufacturing processes could lead to higher levels of formaldehyde exposure during initial use. This risk causes eye irritation, which is the most common effect at low concentrations. The company advised users to run the incubators for a week to reduce formaldehyde levels.
The formaldehyde exposure risk is the most sensitive effect at low concentrations, causing eye irritation. This is a known risk from older manufacturing processes that could lead to higher levels of formaldehyde during initial use.
Parents and caregivers of infants using the affected models of the Giraffe Omnibed Carestation CS1 incubators. The recall includes 52 specific product models that were notified in June 2023 to run for a week to off-gas formaldehyde.
Check if your incubator model matches one of the 52 listed in the recall. The recall includes specific model numbers and UDI codes.
Compare your model number with the list of 52 affected models provided in the recall.
If your incubator is affected, run it for a week to off-gas formaldehyde. This was advised in June 2023.
Watch for eye irritation as the most common effect of formaldehyde exposure at low concentrations.
The risk is eye irritation, which is the most sensitive effect at low concentrations. It is not life-threatening but can cause discomfort.
No replacement is needed. Running the incubator for a week reduces formaldehyde levels. Affected units were notified in June 2023 to run for a week.
Check if your model number matches one of the 52 listed in the recall. The recall includes specific model 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-0140-2025 — Datex-Ohmeda Datex-Ohmeda Hello, I own a Datex-Ohmeda that is covered by recall Z-0140-2025 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.
