GE Healthcare Giraffe Incubator Carestation CS1 recall
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3)…
Why was GE Healthcare Giraffe Incubator Carestation CS1 recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) 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
- Product
- GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3)…
- Recalling firm
- DATEX--OHMEDA, INC.
- Quantity
- 224 units
- Distribution
- worldwide
- Recall date
- November 6, 2024
- Classification
- Class I
- Status
- Completed
- Agency
- FDA (device)