{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217343",
      "product_res_number": "Z-0585-2026",
      "event_date_initiated": "2025-11-12",
      "event_date_posted": "2025-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "97967",
      "product_code": "JTZ",
      "k_numbers": [
        "K790687",
        "K802957"
      ],
      "product_description": "1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10\n\n2. BRUCELLA BROTH, 11ML, 10/BOX YT3450",
      "code_info": "1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993\n\n2. UDI-DI 848838091353, lot 317287",
      "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": "Products may contain contamination, which may result in a darker or brown media color.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters.\n\nCustomers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.",
      "product_quantity": "1,000 US, 280 ROW",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA,\nMD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.",
      "openfda": {
        "k_number": [
          "K780958",
          "K854521",
          "K811608",
          "K853238",
          "K850553",
          "K851589",
          "K851225",
          "K830060",
          "K861301",
          "K864247",
          "K791818",
          "K821429",
          "K864248",
          "K132491",
          "K821607",
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          "K850843",
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          "K870649",
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          "K841213",
          "K864246",
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          "K812581",
          "K863821",
          "K850731",
          "K820846",
          "K842854",
          "K841755",
          "K820794",
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          "K960420",
          "K844892",
          "K790369",
          "K820793",
          "K841138",
          "K841834",
          "K841560",
          "K880105",
          "K833861",
          "K811472",
          "K873268",
          "K840969",
          "K811473",
          "K820792",
          "K800979",
          "K821430",
          "K882351",
          "K871097",
          "K791624",
          "K821428",
          "K780959",
          "K850291",
          "K864245",
          "K851518",
          "K840066",
          "K791485",
          "K832243",
          "K800987",
          "K811049"
        ],
        "device_name": "Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1700",
        "device_class": "2",
        "registration_number": [
          "3009547954",
          "8021914",
          "1120041",
          "2919016",
          "2022807",
          "1530126",
          "1111096",
          "1924669",
          "1119779",
          "8010096"
        ],
        "fei_number": [
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          "3002806332",
          "1000515493",
          "1120041",
          "2919016",
          "2022807",
          "1111096",
          "1924669",
          "1119779",
          "3006224287"
        ]
      }
    }
  ]
}