Reported Nov 6, 2024 · Completed

GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2)…

Datex--Ohmeda, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DATEX--OHMEDA, INC. · 9900 W Innovation Dr · Wauwatosa, WI · 53226-4856

Is this the product you have?

32 of 32 products

Products covered by this recall
#Product as published
12082844-002-01040417
22082844-002-01044956
32082844-002-01058424
42082844-002-01069017
52082844-002-01089666
62082844-002-01090474
72082844-002-01091269
82082844-002-01093489
92082844-002-01113262
102082844-002-01113711
112082844-002-01123085
122082844-002-01123918
132082844-002-01128966
142082844-002-01133042
152082844-002-01146447
162082844-002-100205
172082844-002-100749
182082844-002-100752
192082844-002-100995
202082844-002-101425
Lot codes and dates
  • 1) 2082844-002-01040417
  • UDI

    71 of 71 codes

    • (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
  • 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
Amount recalled
224 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.