{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220907",
      "product_res_number": "Z-2623-2026",
      "event_date_initiated": "2026-06-03",
      "event_date_posted": "2026-06-30",
      "recall_status": "Open, Classified",
      "res_event_number": "99132",
      "product_code": "JTY",
      "k_numbers": [
        "K954986"
      ],
      "product_description": "GC Agar Base (150mm) 10/PK R04030;\nGC Agar Base (100mm) 10/PK R01460",
      "code_info": "R01460 - GC Agar Base (100mm) 10/PK\nUDI-DI 848838001796\nLots\n338950\n356898\n359912\n365679\n371863\n376799\n382136\n384712\n393488\n396333\n402458;\n\nR04030 - GC Agar Base (150mm) 10/PK\nUDI-DI 848838004469\nLots \n336864\n345992\n348754\n359925\n367829\n374235\n376786\n381488\n385224\n391312\n393478",
      "firm_fei_number": "1924669",
      "recalling_firm": "Remel, Inc",
      "address_1": "12076 Santa Fe Trail Dr",
      "city": "Lenexa",
      "state": "KS",
      "postal_code": "66215-3519",
      "additional_info_contact": "Erica Knox\n800-255-6730",
      "reason_for_recall": "Reduced or no recovery of some strains of Neisseria gonorrhoeae.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On June 3, 2026, the firm began notifying customers via letters titled Urgent Medical Device Recall.\n\nCustomers were instructed to destroy any remaining inventory of affected lots and inform the recalling firm of the amount destroyed to receive a replacement or credit. In addition, customers should notify necessary personnel.\n\nUsers should review previously reported results generated using the affected lots and assess whether retesting is appropriate based on laboratory procedures.",
      "product_quantity": "1573",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.",
      "openfda": {
        "k_number": [
          "K791483",
          "K210511",
          "K812078",
          "K850732",
          "K850722",
          "K770287",
          "K791425",
          "K791446",
          "K840159",
          "K830062",
          "K770874",
          "K800977",
          "K881527",
          "K840065",
          "K811645",
          "K800334",
          "K811476",
          "K864253",
          "K851587",
          "K864803",
          "K864252",
          "K840970",
          "K820847",
          "K782117",
          "K933121",
          "K811053",
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          "K871541",
          "K800333",
          "K811282",
          "K841750",
          "K811479",
          "K811281",
          "K770925",
          "K833862",
          "K770875",
          "K840067",
          "K791398",
          "K771871",
          "K823309",
          "K760598",
          "K822552",
          "K831359",
          "K830061",
          "K790368",
          "K791447",
          "K934330",
          "K821551",
          "K791554",
          "K841833",
          "K850841",
          "K860384",
          "K851579",
          "K831124",
          "K791557",
          "K791470",
          "K832862",
          "K993033",
          "K760692",
          "K771872",
          "K832612",
          "K881552",
          "K954986",
          "K780022",
          "K811382",
          "K844014",
          "K864078",
          "K760588",
          "K771035",
          "K854275",
          "K770876",
          "K933122",
          "K931864",
          "K831268",
          "K853237",
          "K821602",
          "K771870",
          "K760690",
          "K934331",
          "K950196",
          "K760693",
          "K843817",
          "K760691"
        ],
        "registration_number": [
          "2951280",
          "1119779",
          "2022807",
          "1111096",
          "3009547954",
          "1924669"
        ],
        "fei_number": [
          "1119779",
          "2022807",
          "1111096",
          "3009547954",
          "1924669",
          "1000221318"
        ],
        "device_name": "Culture Media, For Isolation Of Pathogenic Neisseria",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2410",
        "device_class": "2"
      }
    }
  ]
}