{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210331",
      "product_res_number": "Z-0141-2025",
      "event_date_initiated": "2023-06-06",
      "event_date_posted": "2024-10-31",
      "recall_status": "Completed",
      "res_event_number": "95456",
      "product_code": "FMZ",
      "k_numbers": [
        "K152809",
        "K213553"
      ],
      "product_description": "GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers:  \n1) 2082844-002-01040417; \n2) 2082844-002-01044956; \n3) 2082844-002-01058424; \n4) 2082844-002-01069017; \n5) 2082844-002-01089666; \n6) 2082844-002-01090474; \n7) 2082844-002-01091269; \n8) 2082844-002-01093489; \n9) 2082844-002-01113262; \n10) 2082844-002-01113711; \n11) 2082844-002-01123085; \n12) 2082844-002-01123918; \n13) 2082844-002-01128966; \n14) 2082844-002-01133042; \n15) 2082844-002-01146447; \n16) 2082844-002-100205; \n17) 2082844-002-100749; \n18) 2082844-002-100752; \n19) 2082844-002-100995; \n20) 2082844-002-101425; \n21) 2082844-002-523548; \n22) 2082844-002-529928; \n23) 2082844-002-594800; \n24) 2082844-002-643544; \n25) 2082844-002-925841; \n26) 2082844-002-965540; \n27) 2082844-002-982916; \n28) 2082844-002-983420; \n29) 2082844-002-993905; \n30) 2082844-002-995018; \n31) 2082844-002-995799; \n32) 2082844-002-998943;  Radiant infant warmer",
      "code_info": "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; \n\n2) 2082844-002-01044956, UDI:  (01)008406821168552(21)TAA23140007SA(11)230404, (01)008406821168552(21)TAA23140008SA(11)230404; \n\n3) 2082844-002-01058424, UDI:  (01)00840682116855(21)TAAC70142(11)230213; \n\n4) 2082844-002-01069017, UDI:  (01)008406821168552(21)TAA23110001SA(11)230316, (01)008406821168552(21)TAA23110002SA(11)230316, (01)008406821168552(21)TAA23110003SA(11)230316; \n\n5) 2082844-002-01089666, UDI:  (01)00840682116855(21)TAAC70124(11)230201; \n\n6) 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; \n\n7) 2082844-002-01091269, UDI:  (01)008406821168552(21)TAA23090001SA(11)230228\n228; \n\n8) 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; \n\n9) 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; \n\n10) 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; \n\n11) 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; \n\n12) 2082844-002-01123918, UDI:  (01)008406821168552(21)TAA23130001SA(11)230328; \n\n13) 2082844-002-01128966, UDI:  (01)008406821168552(21)TAA23040022SA(11)230127; \n\n14) 2082844-002-01133042, UDI:  (01)008406821168552(21)TAA23130003SA(11)230328, (01)008406821168552(21)TAA23130004SA(11)230328, (01)008406821168552(21)TAA23130006SA(11)230329; \n\n15) 2082844-002-01146447, UDI:  (01)008406821168552(21)TAA23100001SA(11)230307; \n\n16) 2082844-002-100205, UDI:  (01)008406821168552(21)TAA23030030SA(11)230121; \n\n17) 2082844-002-100749, UDI:  (01)00840682116855(21)TAAC70272(11)230426; \n\n18) 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; \n\n19) 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; \n\n20) 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; \n\n21) 2082844-002-523548, UDI:  (01)00840682116855(21)TAAW62043(11)170130; (01)00840682116855(21)TAAZ70271(11)200224; \n\n22) 2082844-002-529928, UDI:  (01)008406821168552(21)TAA23130002SA(11)230328; \n\n23) 2082844-002-594800, UDI:  (01)00840682116855(21)TAAB70352(11)220520; \n\n24) 2082844-002-643544, UDI:  (01)008406821168552(21)TAA23030023SA(11)230120, (01)008406821168552(21)TAA23030024SA(11)230120, (01)008406821168552(21)TAA23030025SA(11)230120; \n\n25) 2082844-002-925841, UDI:  (01)00840682116855(21)TAAB70547(11)220815; \n\n26) 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; \n\n27) 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; \n\n28) 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; \n\n29) 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; \n\n30) 2082844-002-995018, UDI:  (01)00840682116855(21)TAAB70551(11)220815, (01)00840682116855(21)TAAB70558(11)220819; \n\n31) 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; \n\n32) 2082844-002-998943, UDI:   (01)00840682116855(21)TAAC70050(11)230119, (01)00840682116855(21)TAAC70053(11)230119, (01)00840682116855(21)TAAC70110(11)230130",
      "firm_fei_number": "3014220748",
      "recalling_firm": "DATEX--OHMEDA, INC.",
      "address_1": "9900 W Innovation Dr",
      "city": "Wauwatosa",
      "state": "WI",
      "postal_code": "53226-4856",
      "additional_info_contact": "GE HealthCare Service\n800-437-1171",
      "reason_for_recall": "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.",
      "root_cause_description": "Component design/selection",
      "action": "GE HealthCare notified its consignees of the issue by letter beginning on 06/06/2023 using a traceable means.  The notice explained the issue of potentially higher levels of formaldehyde which rapidly decrease of a week, and instructions on how to accelerate the rate of dissipation if the unit had not yet been put into clinical use.  \nFor questions:  contact 1-800-437-1171 or your local GE HealthCare Representative",
      "product_quantity": "224 units",
      "distribution_pattern": "worldwide",
      "openfda": {
        "k_number": [
          "K813239",
          "K900735",
          "K813238",
          "K802639",
          "K822656",
          "K801461",
          "K924170",
          "K251619",
          "K040910",
          "K101778",
          "K003067",
          "K954204",
          "K903378",
          "K781876",
          "K943360",
          "K920049",
          "K053399",
          "K974349",
          "K101788",
          "K912000",
          "K132543",
          "K832418",
          "K962806",
          "K182859",
          "K914487",
          "K912910",
          "K901585",
          "K884086",
          "K061280",
          "K912909",
          "K260326",
          "K871399",
          "K070291",
          "K993712",
          "K102226",
          "K840526",
          "K182977",
          "K901157",
          "K914134",
          "K102279",
          "K213553",
          "K071175",
          "K243437",
          "K922618",
          "K190494",
          "K881476",
          "K895550",
          "K940975",
          "K924297",
          "K020547",
          "K870223",
          "K900752",
          "K915752",
          "K870222",
          "K172154",
          "K152809",
          "K040068",
          "K821896",
          "K102710",
          "K031387",
          "K010222",
          "K152814",
          "K251663",
          "K061856",
          "K924324",
          "K162821",
          "K890476",
          "K071977",
          "K780472",
          "K020543",
          "K960980",
          "K021809",
          "K914864",
          "K810067",
          "K895782",
          "K001242",
          "K810792",
          "K913154",
          "K993407",
          "K802126",
          "K913291",
          "K993051",
          "K913394",
          "K802640",
          "K980886",
          "K072512"
        ],
        "device_name": "Incubator, Neonatal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5400",
        "device_class": "2",
        "registration_number": [
          "",
          "3012348048",
          "9611500",
          "1055236",
          "3001104093",
          "3021559257",
          "1000122786",
          "1054713",
          "3007734888",
          "1054241",
          "3030089838",
          "3009077524",
          "1066270",
          "1034876",
          "9613793",
          "1226711",
          "3006179052",
          "3008729547",
          "3005934741",
          "3014220748",
          "1043214",
          "3005652389",
          "3036470679",
          "9710602",
          "2510954"
        ],
        "fei_number": [
          "",
          "3012348048",
          "3001104093",
          "3021559257",
          "1000122786",
          "3007734888",
          "1000114111",
          "3030089838",
          "3009077524",
          "3023530182",
          "3003338236",
          "3004846435",
          "1034876",
          "3006179052",
          "3008729547",
          "3005934741",
          "3014220748",
          "3000957797",
          "1043214",
          "1000112877",
          "3003513129",
          "3036470679",
          "2510954",
          "1000112968",
          "3006469671"
        ]
      }
    }
  ]
}