# FDA recall Z-0141-2025

> **DATEX--OHMEDA, INC.** · Class I · device recall initiated 2023-06-06.

## Product

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

## Reason for recall

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.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0141-2025
- **Recalling firm:** DATEX--OHMEDA, INC.
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-06-06
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wauwatosa, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2025

## Citation

> AI Analytics. FDA recall Z-0141-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0141-2025. Source: US FDA. Licensed CC0.

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