{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195618",
      "product_res_number": "Z-1768-2022",
      "event_date_initiated": "2022-07-27",
      "event_date_created": "2022-09-19",
      "recall_status": "Completed",
      "res_event_number": "90743",
      "product_code": "LYA",
      "k_numbers": [
        "K060878"
      ],
      "product_description": "ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM",
      "code_info": "UDI/DI 00860003109915, Batch Numbers:  T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026",
      "firm_fei_number": "3010208179",
      "recalling_firm": "GELITA MEDICAL GMBH",
      "address_1": "Uferstr. 7 7 uferstr.",
      "city": "Eberbach",
      "country": "Germany",
      "additional_info_contact": "496271842021",
      "reason_for_recall": "In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm emailed a Field Safety Notice to the sole consignee, a distributor, on 07/27/2022, 08/11/2022 and 08/15/2022.  The first letter explained the problem, hazard, and requested the return of the product.  If the product was further distributed to notify customers.  The second and third letters requested that the recalled articles be destroyed.",
      "product_quantity": "3596 boxes of 50 devices",
      "distribution_pattern": "US Nationwide distribution in the state of Alabama.",
      "openfda": {
        "k_number": [
          "K052099",
          "K954449",
          "K070496",
          "K141423",
          "K952207",
          "K243655",
          "K140992",
          "K972096",
          "K132721",
          "K080247",
          "K901307",
          "K925173",
          "K153686",
          "K972092",
          "K063308",
          "K113585",
          "K181696",
          "K122494",
          "K952226",
          "K921202",
          "K935658",
          "K213153",
          "K202623",
          "K012532",
          "K980221",
          "K935053",
          "K141704",
          "K933152",
          "K945555",
          "K230142",
          "K830263",
          "K180141",
          "K002131",
          "K972082",
          "K041381",
          "K170913",
          "K981374",
          "K141816",
          "K172179",
          "K972151",
          "K082276",
          "K901306",
          "K921195",
          "K130354",
          "K011544",
          "K092401"
        ],
        "device_name": "Splint, Intranasal Septal",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.4780",
        "device_class": "1",
        "registration_number": [
          "3010952189",
          "3016678045",
          "3032857006",
          "3007788086",
          "3013187142",
          "1625425",
          "1526711",
          "3010872396",
          "1649518",
          "3040335671",
          "9612501",
          "3003477135",
          "3004050854",
          "1045254",
          "2031093",
          "3015174190",
          "3010951382",
          "3012448339",
          "3003915875",
          "3002789796",
          "1048735",
          "3006524618",
          "3007225047",
          "1926681",
          "3002858762",
          "3030733800",
          "3010880816",
          "3008719017",
          "3010487482",
          "1424263",
          "3034731665",
          "9612051",
          "8010177",
          "3011088743",
          "3010273872",
          "3006789548",
          "2183319",
          "3010951384",
          "2183744",
          "2110420",
          "3012358417",
          "1061124",
          "3009337401",
          "3002807315",
          "3030653921",
          "3002806470",
          "3015967359",
          "3021082429",
          "1643264",
          "3003364789",
          "1423662",
          "3009134882",
          "3010610457",
          "1219795",
          "3004111573",
          "3015337116",
          "1213643",
          "3017475063",
          "3004146122",
          "1058584",
          "3009403363",
          "1645368",
          "3006113097",
          "3005112833",
          "3003790304",
          "3014507028",
          "2028632",
          "3014345718",
          "1220477",
          "1226544",
          "1223089",
          "3007327621",
          "3011400126",
          "3013674629",
          "1319660",
          "3006306415",
          "1450662",
          "3011050570",
          "3008729892",
          "3003418325",
          "1037007",
          "2032098",
          "2135339",
          "3003775072",
          "3016426830",
          "3008812251",
          "2246552",
          "1052728",
          "1928237",
          "3013517086",
          "3022140316",
          "3043562110",
          "3014653790",
          "3016050930",
          "1043534",
          "3017636737",
          "3002806953",
          "3005941719",
          "2022502",
          "1219071",
          "9611024",
          "3018094310",
          "1018470",
          "2028807",
          "2029275",
          "3023464160"
        ],
        "fei_number": [
          "3010952189",
          "3016678045",
          "3032857006",
          "1000120505",
          "3007788086",
          "3013187142",
          "1625425",
          "1000117860",
          "1526711",
          "3003495548",
          "3010872396",
          "3040335671",
          "1000306431",
          "3003058448",
          "3003477135",
          "1000159144",
          "1000512168",
          "3004050854",
          "1045254",
          "3015174190",
          "3010951382",
          "3012448339",
          "3003915875",
          "3002789796",
          "1048735",
          "3007225047",
          "1926681",
          "3002858762",
          "3002821504",
          "3030733800",
          "3010880816",
          "3008719017",
          "1000374126",
          "3010487482",
          "3034731665",
          "3010813691",
          "3011088743",
          "3010273872",
          "3001236277",
          "3006789548",
          "3001236549",
          "2183319",
          "3010951384",
          "3002807170",
          "2183744",
          "2110420",
          "3012358417",
          "3002808293",
          "3009337401",
          "3002807315",
          "3030653921",
          "3002806470",
          "3002807555",
          "3015967359",
          "3021082429",
          "1643264",
          "3003364789",
          "3000215273",
          "3009134882",
          "3010610457",
          "1219795",
          "3004111573",
          "3015337116",
          "1213643",
          "3017475063",
          "3002807111",
          "3004146122",
          "3009403363",
          "1000125025",
          "3006113097",
          "3005112833",
          "3003790304",
          "3014507028",
          "1000136478",
          "1000219637",
          "1000113735",
          "3014345718",
          "1220477",
          "3007327621",
          "3011400126",
          "3013674629",
          "1450662",
          "3006306415",
          "3011050570",
          "3003015552",
          "3007867940",
          "3003418325",
          "1037007",
          "3003775072",
          "3016426830",
          "2246552",
          "1928237",
          "3013517086",
          "3022140316",
          "3043562110",
          "3014653790",
          "3016050930",
          "1043534",
          "3017636737",
          "3002806457",
          "3002806953",
          "2022502",
          "3018094310",
          "1018470",
          "3003128516",
          "3023464160"
        ]
      }
    }
  ]
}