FDA Device recall Z-0140-2025
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer
- FDA Device
- Class I
- completed
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class I recall of GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer by Datex Ohmeda, citing prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that wou….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0140-2025 |
| Classification | Class I |
| Status | completed |
| Initiated | 2023-06-06 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Datex Ohmeda |
| Distribution | n/a |
Product
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
Reason
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.
Identifiers
| code_info | 1) 2082844-001-01040418, UDI: (01)00840682116862(21)TABC70024(11)230203, (01)00840682116862(21)TABC70035(11)230207, (0…1) 2082844-001-01040418, UDI: (01)00840682116862(21)TABC70024(11)230203, (01)00840682116862(21)TABC70035(11)230207, (01)00840682116862(21)TABC70037(11)230207, (01)00840682116862(21)TABC70038(11)230207, (01)00840682116862(21)TABC70045(11)230208, (01)00840682116862(21)TABC70052(11)230209, (01)00840682116862(21)TABC70054(11)230209, (01)00840682116862(21)TABC70056(11)230209, (01)00840682116862(21)TABC70060(11)230209, (01)00840682116862(21)TABC70064(11)230210, (01)00840682116862(21)TABC70068(11)230210, (01)00840682116862(21)TABC70069(11)230210, (01)00840682116862(21)TABC70070(11)230210; 2) 2082844-001-01046784, UDI: (01)008406821168622(21)TAB23060007SA(11)230209, (01)008406821168622(21)TAB23060008SA(11)230209, (01)008406821168622(21)TAB23060009SA(11)230209, (01)008406821168622(21)TAB23060010SA(11)230209, (01)008406821168622(21)TAB23060011SA(11)230209, (01)008406821168622(21)TAB23060012SA(11)230209, (01)008406821168622(21)TAB23060013SA(11)230209, (01)008406821168622(21)TAB23060014SA(11)2 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0140-2025%22
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