Product Safety Recalls

Product Recall Tracker

DATEX–OHMEDA, INC. Recall 95456

Description: 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

DATEX–OHMEDA, INC. Recall 95456 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0141-2025
Event ID95456
Event DescriptionGE 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
Product TypeDevices
Distributionworldwide
Quantity224 units
Recall ReasonPrior 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.
Device Classification20241106
Device Code Info1) 2082844-002-01040417, UDI: (01)00840682116855(21)TAAC70003(11)230106, (01)00840682116855(21)TAAC70004(11)230109, (01)00840682116855(21)TAAC70011(11)230110, (01)00840682116855(21)TAAC70012(11)230110, (01)00840682116855(21)TAAC70013(11)230111, (01)00840682116855(21)TAAC70015(11)230112, (01)00840682116855(21)TAAC70016(11)230112, (01)00840682116855(21)TAAC70020(11)230112, (01)00840682116855(21)TAAC70022(11)230112, (01)00840682116855(21)TAAC70024(11)230112, (01)00840682116855(21)TAAC70147(11)230317, (01)00840682116855(21)TAAC70148(11)230317, (01)00840682116855(21)TAAC70149(11)230317, (01)00840682116855(21)TAAC70150(11)230317, (01)00840682116855(21)TAAC70152(11)230320, (01)00840682116855(21)TAAC70153(11)230320, (01)00840682116855(21)TAAC70155(11)230322, (01)00840682116855(21)TAAC70158(11)230322, (01)00840682116855(21)TAAC70159(11)230323, (01)00840682116855(21)TAAC70160(11)230323, (01)00840682116855(21)TAAC70161(11)230323, (01)00840682116855(21)TAAC70162(11)230323, (01)00840682116855(21)TAAC70163(11)230324, (01)00840682116855(21)TAAC70164(11)230324, (01)00840682116855(21)TAAC70165(11)230324, (01)00840682116855(21)TAAC70166(11)230324, (01)00840682116855(21)TAAC70167(11)230327, (01)00840682116855(21)TAAC70169(11)230327, (01)00840682116855(21)TAAC70170(11)230327, (01)00840682116855(21)TAAC70171(11)230328, (01)00840682116855(21)TAAC70177(11)230330, (01)00840682116855(21)TAAC70178(11)230330, (01)00840682116855(21)TAAC70179(11)230331, (01)00840682116855(21)TAAC70181(11)230331, (01)00840682116855(21)TAAC70182(11)230331, (01)00840682116855(21)TAAC70184(11)230331, (01)00840682116855(21)TAAC70192(11)230405, (01)00840682116855(21)TAAC70193(11)230405, (01)00840682116855(21)TAAC70196(11)230405, (01)00840682116855(21)TAAC70197(11)230405, (01)00840682116855(21)TAAC70200(11)230407, (01)00840682116855(21)TAAC70201(11)230407, (01)00840682116855(21)TAAC70202(11)230407, (01)00840682116855(21)TAAC70203(11)230407, (01)00840682116855(21)TAAC70204(11)230407, (01)00840682116855(21)TAAC70205(11)230407, (01)00840682116855(21)TAAC70208(11)230411, (01)00840682116855(21)TAAC70209(11)230411, (01)00840682116855(21)TAAC70210(11)230411, (01)00840682116855(21)TAAC70211(11)230414, (01)00840682116855(21)TAAC70212(11)230414, (01)00840682116855(21)TAAC70213(11)230414, (01)00840682116855(21)TAAC70214(11)230414, (01)00840682116855(21)TAAC70215(11)230417, (01)00840682116855(21)TAAC70216(11)230417, (01)00840682116855(21)TAAC70217(11)230417, (01)00840682116855(21)TAAC70218(11)230417, (01)00840682116855(21)TAAC70223(11)230418, (01)00840682116855(21)TAAC70224(11)230418, (01)00840682116855(21)TAAC70225(11)230418, (01)00840682116855(21)TAAC70226(11)230418, (01)00840682116855(21)TAAC70227(11)230418, (01)00840682116855(21)TAAC70228(11)230418, (01)00840682116855(21)TAAC70229(11)230419, (01)00840682116855(21)TAAC70242(11)230421, (01)00840682116855(21)TAAC70243(11)230421, (01)00840682116855(21)TAAC70244(11)230421, (01)00840682116855(21)TAAC70245(11)230421, (01)00840682116855(21)TAAC70246(11)230421, (01)00840682116855(21)TAAC70247(11)230421; 2) 2082844-002-01044956, UDI: (01)008406821168552(21)TAA23140007SA(11)230404, (01)008406821168552(21)TAA23140008SA(11)230404; 3) 2082844-002-01058424, UDI: (01)00840682116855(21)TAAC70142(11)230213; 4) 2082844-002-01069017, UDI: (01)008406821168552(21)TAA23110001SA(11)230316, (01)008406821168552(21)TAA23110002SA(11)230316, (01)008406821168552(21)TAA23110003SA(11)230316; 5) 2082844-002-01089666, UDI: (01)00840682116855(21)TAAC70124(11)230201; 6) 2082844-002-01090474, UDI: (01)00840682116855(21)TAAC70126(11)230201, (01)00840682116855(21)TAAC70128(11)230206, (01)00840682116862(21)TAAC70132(11)230206, (01)00840682116855(21)TAAC70133(11)230206, (01)00840682116855(21)TAAC70125(11)230201, (01)00840682116855(21)TAAC70127(11)230206, (01)00840682116855(21)TAAC70129(11)230206, (01)00840682116855(21)TAAC70131(11)230206, (01)00840682116855(21)TAAC70136(11)230206, (01)00840682116855(21)TAAC70137(11)230206; 7) 2082844-002-01091269, UDI: (01)008406821168552(21)TAA23090001SA(11)230228 228; 8) 2082844-002-01093489, UDI: (01)00840682116855(21)TAAC70187(11)230403, (01)00840682116855(21)TAAC70188(11)230403, (01)00840682116855(21)TAAC70189(11)230403, (01)00840682116855(21)TAAC70190(11)230403, (01)00840682116855(21)TAAC70191(11)230403; 9) 2082844-002-01113262, UDI: (01)008406821168552(21)TAA23050010SA(11)230130, (01)008406821168552(21)TAA23050011SA(11)230130, (01)008406821168552(21)TAA23050012SA(11)230130, (01)008406821168552(21)TAA23050013SA(11)230130; 10) 2082844-002-01113711, UDI: (01)008406821168552(21)TAA23130005SA(11)230328, (01)008406821168552(21)TAA23130007SA(11)230329, (01)008406821168552(21)TAA23130008SA(11)230329, (01)008406821168552(21)TAA23130009SA(11)230329; 11) 2082844-002-01123085, UDI: (01)008406821168552(21)TAA23190005SA(11)230513, (01)008406821168552(21)TAA23190006SA(11)230513, (01)008406821168552(21)TAA23190007SA(11)230513, (01)008406821168552(21)TAA23190008SA(11)230513, (01)008406821168552(21)TAA23190009SA(11)230513, (01)008406821168552(21)TAA23190010SA(11)230513; 12) 2082844-002-01123918, UDI: (01)008406821168552(21)TAA23130001SA(11)230328; 13) 2082844-002-01128966, UDI: (01)008406821168552(21)TAA23040022SA(11)230127; 14) 2082844-002-01133042, UDI: (01)008406821168552(21)TAA23130003SA(11)230328, (01)008406821168552(21)TAA23130004SA(11)230328, (01)008406821168552(21)TAA23130006SA(11)230329; 15) 2082844-002-01146447, UDI: (01)008406821168552(21)TAA23100001SA(11)230307; 16) 2082844-002-100205, UDI: (01)008406821168552(21)TAA23030030SA(11)230121; 17) 2082844-002-100749, UDI: (01)00840682116855(21)TAAC70272(11)230426; 18) 2082844-002-100752, UDI: (01)00840682116855(21)TAAC70075(11)230123, (01)00840682116855(21)TAAC70083(11)230124, (01)00840682116855(21)TAAC70084(11)230124, (01)00840682116855(21)TAAC70086(11)230125, (01)00840682116855(21)TAAC70087(11)230125; 19) 2082844-002-100995, UDI: (01)008406821168552(21)TAA23090003SA(11)230228, (01)008406821168552(21)TAA23090004SA(11)230228, (01)008406821168552(21)TAA23090005SA(11)230228, (01)008406821168552(21)TAA23090006SA(11)230228, (01)008406821168552(21)TAA23090002SA(11)230228, (01)008406821168552(21)TAA23090007SA(11)230228; 20) 2082844-002-101425, UDI: (01)008406821168552(21)TAA23190003SA(11)230512, (01)008406821168552(21)TAA23160001SA(11)230419, (01)008406821168552(21)TAA23170001SA(11)230424, (01)008406821168552(21)TAA23130031SA(11)230331, (01)008406821168552(21)TAA23130032SA(11)230331, (01)008406821168552(21)TAA23130033SA(11)230331, (01)008406821168552(21)TAA23130034SA(11)230331, (01)008406821168552(21)TAA23130035SA(11)230331, (01)008406821168552(21)TAA23130036SA(11)230331, (01)008406821168552(21)TAA23130021SA(11)230330, (01)00840682116855(21)TAAC70143(11)230224, (01)00840682116855(21)TAAC70144(11)230224, (01)00840682116855(21)TAAC70145(11)230224, (01)008406821168552(21)TAA23130025SA(11)230331, (01)008406821168552(21)TAA23130026SA(11)230331, (01)008406821168552(21)TAA23130027SA(11)230331, (01)008406821168552(21)TAA23130028SA(11)230331, (01)008406821168552(21)TAA23130029SA(11)230331, (01)008406821168552(21)TAA23130030SA(11)230331, (01)00840682116855(21)TAAC70146(11)230313, (01)008406821168552(21)TAA23140001SA(11)230403, (01)008406821168552(21)TAA23140002SA(11)230403, (01)008406821168552(21)TAA23130022SA(11)230330, (01)008406821168552(21)TAA23130023SA(11)230330, (01)008406821168552(21)TAA23130024SA(11)230330, (01)008406821168552(21)TAA23160002SA(11)230419; 21) 2082844-002-523548, UDI: (01)00840682116855(21)TAAW62043(11)170130; (01)00840682116855(21)TAAZ70271(11)200224; 22) 2082844-002-529928, UDI: (01)008406821168552(21)TAA23130002SA(11)230328; 23) 2082844-002-594800, UDI: (01)00840682116855(21)TAAB70352(11)220520; 24) 2082844-002-643544, UDI: (01)008406821168552(21)TAA23030023SA(11)230120, (01)008406821168552(21)TAA23030024SA(11)230120, (01)008406821168552(21)TAA23030025SA(11)230120; 25) 2082844-002-925841, UDI: (01)00840682116855(21)TAAB70547(11)220815; 26) 2082844-002-965540, UDI: (01)00840682116855(21)TAAB70617(11)220826, (01)00840682116855(21)TAAB70665(11)220928, (01)00840682116855(21)TAAB70666(11)220928, (01)00840682116855(21)TAAB70670(11)220929, (01)00840682116855(21)TAAB70671(11)220929, (01)00840682116855(21)TAAB70681(11)221003, (01)00840682116855(21)TAAB70691(11)221004, (01)00840682116855(21)TAAB70702(11)221005, (01)00840682116855(21)TAAB70703(11)221005, (01)00840682116855(21)TAAB70732(11)221010; 27) 2082844-002-982916, UDI: (01)00840682116855(21)TAAC70033(11)230113, (01)00840682116855(21)TAAC70037(11)230116, (01)00840682116855(21)TAAC70044(11)230116, (01)00840682116855(21)TAAC70052(11)230119, (01)00840682116855(21)TAAC70058(11)230119, (01)00840682116855(21)TAAC70059(11)230119, (01)00840682116855(21)TAAC70060(11)230119, (01)00840682116855(21)TAAC70065(11)230120, (01)00840682116855(21)TAAC70067(11)230123, (01)00840682116855(21)TAAC70068(11)230123, (01)00840682116855(21)TAAB70608(11)220824; 28) 2082844-002-983420, UDI: (01)00840682116855(21)TAAC70076(11)230123, (01)00840682116855(21)TAAC70078(11)230124, (01)00840682116855(21)TAAC70079(11)230124, (01)00840682116855(21)TAAC70082(11)230124, (01)00840682116855(21)TAAC70089(11)230125, (01)00840682116855(21)TAAC70090(11)230125, (01)00840682116855(21)TAAC70092(11)230126, (01)00840682116855(21)TAAC70093(11)230126; 29) 2082844-002-993905, UDI: (01)008406821168552(21)TAA23040004SA(11)230123, (01)008406821168552(21)TAA23040005SA(11)230123, (01)008406821168552(21)TAA23040006SA(11)230124, (01)008406821168552(21)TAA23050014SA(11)230130; 30) 2082844-002-995018, UDI: (01)00840682116855(21)TAAB70551(11)220815, (01)00840682116855(21)TAAB70558(11)220819; 31) 2082844-002-995799, UDI: (01)008406821168552(21)TAA23040019SA(11)230127, (01)008406821168552(21)TAA23040020SA(11)230127, (01)008406821168552(21)TAA23190004SA(11)230513, (01)008406821168552(21)TAA23160007SA(11)230420, (01)008406821168552(21)TAA23160009SA(11)230420, (01)008406821168552(21)TAA23130015SA(11)230329, (01)008406821168552(21)TAA23130016SA(11)230329, (01)008406821168552(21)TAA23130017SA(11)230329, (01)008406821168552(21)TAA23130018SA(11)230329, (01)008406821168552(21)TAA23130020SA(11)230329, (01)008406821168552(21)TAA23160003SA(11)230419, (01)008406821168552(21)TAA23160004SA(11)230419, (01)008406821168552(21)TAA23160005SA(11)230419, (01)008406821168552(21)TAA23160006SA(11)230419, (01)008406821168552(21)TAA23160008SA(11)230420, (01)008406821168552(21)TAA23160010SA(11)230420, (01)008406821168552(21)TAA23160011SA(11)230420, (01)008406821168552(21)TAA23200003SA(11)230515, (01)008406821168552(21)TAA23200004SA(11)230515, (01)008406821168552(21)TAA23200005SA(11)230515, (01)008406821168552(21)TAA23200006SA(11)230515, (01)008406821168552(21)TAA23200007SA(11)230515, (01)008406821168552(21)TAA23200008SA(11)230515, (01)008406821168552(21)TAA23200009SA(11)230515, (01)008406821168552(21)TAA23200010SA(11)230515, (01)008406821168552(21)TAA23130019SA(11)230329; 32) 2082844-002-998943, UDI: (01)00840682116855(21)TAAC70050(11)230119, (01)00840682116855(21)TAAC70053(11)230119, (01)00840682116855(21)TAAC70110(11)230130
Center Classification Date20241031
Recall Initiation Date20230606
Recalling FirmDATEX--OHMEDA, INC.
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.