FDAFDA · Food and drugs·Recall number Z-0140-2025

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

Published November 6, 2024 · Recall initiated: June 6, 2023

Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: DATEX--OHMEDA, INC.
Distributor: worldwide
Lot: 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)230209, (01)008406821168622(21)TAB23060015SA(11)230209; 3) 2082844-001-01052324, UDI: (01)00840682116862(21)TABC70169(11)230228; 4) 2082844-001-01052572, UDI: (01)00840682116862(21)TABC70101(11)230215, (01)00840682116862(21)TABC70119(11)230217, (01)00840682116862(21)TABC70130(11)230220, (01)00840682116862(21)TABC70136(11)230221, (01)00840682116862(21)TABC70138(11)230222, (01)00840682116862(21)TABC70171(11)230301, (01)00840682116862(21)TABC70180(11)230302, (01)00840682116862(21)TABC70196(11)230306, (01)00840682116862(21)TABC70269(11)230315, (01)00840682116862(21)TABC70270(11)230316, (01)00840682116862(21)TABC70271(11)230316; 5) 2082844-001-01055337, UDI: (01)00840682116862(21)TABC70189(11)230303; 6) 2082844-001-01065693, UDI: (01)00840682116862(21)TABC70349(11)230410; 7) 2082844-001-01069008, UDI: (01)008406821168622(21)TAB23090049SA(11)230304, (01)008406821168622(21)TAB23090050SA(11)230304, (01)008406821168622(21)TAB23090051SA(11)230304, (01)008406821168622(21)TAB23090052SA(11)230304; 8) 2082844-001-01073750, UDI: (01)00840682116862(21)TABC70104(11)230215, (01)00840682116862(21)TABC70190(11)230303, (01)00840682116862(21)TABC70197(11)230306; 9) 2082844-001-01086553, UDI: (01)008406821168622(21)TAB23020017SA(11)230110, (01)008406821168622(21)TAB23020018SA(11)230110, (01)008406821168622(21)TAB23020019SA(11)230110, (01)008406821168622(21)TAB23020020SA(11)230110; 10) 2082844-001-01089393, UDI: (01)00840682116862(21)TABC70289(11)230320, (01)00840682116862(21)TABC70293(11)230322, (01)00840682116862(21)TABC70299(11)230322, (01)00840682116862(21)TABC70307(11)230323, (01)00840682116862(21)TABC70309(11)230324, (01)00840682116862(21)TABC70310(11)230324, (01)00840682116862(21)TABC70314(11)230327, (01)00840682116862(21)TABC70316(11)230328, (01)00840682116862(21)TABC70320(11)230328, (01)00840682116862(21)TABC70321(11)230328, (01)00840682116862(21)TABC70323(11)230329, (01)00840682116862(21)TABC70327(11)230330, (01)00840682116862(21)TABC70328(11)230330, (01)00840682116862(21)TABC70329(11)230330, (01)00840682116862(21)TABC70335(11)230405, (01)00840682116862(21)TABC70337(11)230405, (01)00840682116862(21)TABC70338(11)230405, (01)00840682116862(21)TABC70339(11)230405, (01)00840682116862(21)TABC70341(11)230406, (01)00840682116862(21)TABC70342(11)230406, (01)00840682116862(21)TABC70343(11)230406, (01)00840682116862(21)TABC70344(11)230406, (01)00840682116862(21)TABC70350(11)230410, (01)00840682116862(21)TABC70351(11)230410, (01)00840682116862(21)TABC70352(11)230411, (01)00840682116862(21)TABC70106(11)230215, (01)00840682116862(21)TABC70125(11)230220, (01)00840682116862(21)TABC70141(11)230222, (01)00840682116862(21)TABC70147(11)230223, (01)00840682116862(21)TABC70148(11)230224, (01)00840682116862(21)TABC70160(11)230227, (01)00840682116862(21)TABC70161(11)230227, (01)00840682116862(21)TABC70165(11)230228, (01)00840682116862(21)TABC70175(11)230301, (01)00840682116862(21)TABC70182(11)230302; 11) 2082844-001-01090414, UDI: (01)008406821168622(21)TAB
Risk classification: Class I
Area (FDA): device
Country: United States

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