{
  "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": "197247",
      "product_res_number": "Z-0473-2023",
      "event_date_initiated": "2022-11-21",
      "event_date_posted": "2022-12-09",
      "recall_status": "Open, Classified",
      "res_event_number": "91201",
      "product_code": "JTY",
      "product_description": "BBL Chocolate II Agar-  IVD for the isolation and cultivation of Neisseria species.\nCatalog (Ref) Number: 221267",
      "code_info": "UDI: (10)2206461(17)221125(30)0100\n\nLot Number: 2206461\nExp. Date: 20221125.\n\nBox numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).",
      "firm_fei_number": "1119779",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "7 Loveton Cir",
      "city": "Sparks",
      "state": "MD",
      "postal_code": "21152-9212",
      "reason_for_recall": "Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.",
      "root_cause_description": "Under Investigation by firm",
      "action": "BD initiated the recall on November 21, 2022 via Urgent Medical Device Correction Letter.\nto Distributors and Risk Managers. Letter states reason for recall, health risk and action to take: Immediately inspect your inventory for the specific catalog and lot number listed above. Affected product includes box numbers 0002 through 0097. These boxes correlate to timestamps on the plates of 11:34 through 13:51. Timestamps can be found on the bottom of the plate. The box number can be located on the 2. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness.\n3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements.\nDistributors: As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this notification. Email an excel file listing of all customers to BDRC4@bd.com within 72 hours of receipt of this letter so that BD may initiate customer notification.\n\nActions Taken by BD:\n BD will issue replacements following receipt of the completed Customer Response Form.\nQuestions: North American Regional Complaint Center .Phone: 1-844-8BD-LIFE (1-844-823-5433) Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com",
      "product_quantity": "9,600 EA",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.",
      "openfda": {
        "k_number": [
          "K832862",
          "K851579",
          "K791554",
          "K840159",
          "K931864",
          "K993033",
          "K791398",
          "K811479",
          "K843817",
          "K811382",
          "K831359",
          "K812078",
          "K853237",
          "K860384",
          "K840970",
          "K800977",
          "K840065",
          "K782117",
          "K811281",
          "K791447",
          "K760598",
          "K832948",
          "K210511",
          "K790368",
          "K871541",
          "K760588",
          "K830062",
          "K864078",
          "K934330",
          "K864252",
          "K800333",
          "K954986",
          "K811282",
          "K820847",
          "K760690",
          "K780022",
          "K833862",
          "K934331",
          "K770875",
          "K841833",
          "K760692",
          "K864803",
          "K771035",
          "K811645",
          "K881527",
          "K811476",
          "K770925",
          "K822552",
          "K770874",
          "K854275",
          "K823309",
          "K851587",
          "K791446",
          "K791425",
          "K771870",
          "K800334",
          "K831124",
          "K850722",
          "K770287",
          "K791470",
          "K811053",
          "K771872",
          "K821551",
          "K760693",
          "K881552",
          "K850841",
          "K791557",
          "K850732",
          "K841750",
          "K832612",
          "K760691",
          "K791483",
          "K950196",
          "K933121",
          "K770876",
          "K831268",
          "K840067",
          "K933122",
          "K821602",
          "K844014",
          "K771871",
          "K864253",
          "K830061"
        ],
        "registration_number": [
          "2022807",
          "1119779",
          "1111096",
          "1924669",
          "3009547954",
          "2951280"
        ],
        "fei_number": [
          "2022807",
          "1119779",
          "1111096",
          "1924669",
          "3009547954",
          "1000221318"
        ],
        "device_name": "Culture Media, For Isolation Of Pathogenic Neisseria",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2410",
        "device_class": "2"
      }
    }
  ]
}