{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "195715",
      "product_res_number": "Z-1822-2022",
      "event_date_initiated": "2022-08-12",
      "event_date_posted": "2022-09-28",
      "recall_status": "Open, Classified",
      "res_event_number": "90782",
      "product_code": "MQG",
      "k_numbers": [
        "K121566"
      ],
      "product_description": "Humidifier bottle and syringe filter kit (6 count of each) for the BT37\nMark I Benchtop Incubator (AY102295).\n\nThe Mark I model is no longer produced, but the legacy humidifier\nbottle component design can also be used with the BT37 Mark II\nBenchtop Incubator.",
      "code_info": "Lot Numbers\n\n05593V291121\n18-1192\n1812-68\n18-1268\nG000575 \nG003811 \nG003893 \nG004517 \nG004874 \nG005109 \nG005476 \nG005723 \nE160415\n\nExpiration date range: 27 Jun 2022 to 07 Dec 2024",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "95 Corporate Dr",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-1350",
      "additional_info_contact": "Customer Service\n203-601-5200 Ext. 03300",
      "reason_for_recall": "There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On August 12, 2022, the firm notified customers via an Urgent Medical Device Safety Notice.\n\nCustomers were instructed to quarantine affected product in their inventory. Once customers complete and return the Acknowledgement and Receipt Form attached to the recall letter, the firm will arrange for the affected product to be returned at no cost. Customers will receive credit for returned affected product.\n\nCooperSurgical may be reached at 203-601-5200 ext. 03300 or recall@coopersurgical.com.",
      "product_quantity": "5,182 kits",
      "distribution_pattern": "Domestic distribution to the following states:\nAL\nAZ\nCA\nCT\nDE\nFL\nGA\nHI\nIL\nKS\nMA\nMI\nMN\nMO\nNJ\nNY\nOH\nOR\nSC\nTX\nVA\nVT\nWA\nWI\nWV\n\nForeign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.",
      "openfda": {
        "k_number": [
          "K003184",
          "K261083",
          "K111715",
          "K020560",
          "K021042",
          "K991229",
          "K002595",
          "K002961",
          "K260194",
          "K013401",
          "K133742",
          "K180188",
          "K983642",
          "K032526",
          "K014160",
          "K992070",
          "K001600",
          "K002805",
          "K991263",
          "K001524",
          "K991408",
          "K030525",
          "K991216",
          "K011327",
          "K050197",
          "K160753",
          "K032086",
          "K092183",
          "K160504",
          "K101988",
          "K121566",
          "K113075",
          "K983609",
          "K173264",
          "K151357",
          "K023465",
          "K132870",
          "K180304",
          "K232493",
          "K000394",
          "K001486",
          "K002971",
          "K242684",
          "K133712",
          "K041952",
          "K013703",
          "K171736"
        ],
        "registration_number": [
          "1000393132",
          "3005580113",
          "3009107689",
          "3023235140",
          "1216677",
          "9610632",
          "3008157119",
          "1820334",
          "3017247483",
          "9680654",
          "3003775072",
          "3004871219",
          "1066270",
          "3006405073",
          "1221433",
          "3034431159",
          "3009747883",
          "3031594904",
          "1222779",
          "9613662",
          "1825146",
          "3012853704",
          "1523845",
          "3003244268"
        ],
        "fei_number": [
          "1000393132",
          "3000957797",
          "3005580113",
          "3009107689",
          "3023235140",
          "1216677",
          "3008157119",
          "1820334",
          "3017247483",
          "3003775072",
          "3006405073",
          "1221433",
          "3034431159",
          "1000120774",
          "3009747883",
          "3031594904",
          "3007530363",
          "1825146",
          "3012853704",
          "3003751666",
          "1523845",
          "3002919051",
          "3003244268",
          "3002808026"
        ],
        "device_name": "Accessory, Assisted Reproduction",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6120",
        "device_class": "2"
      }
    }
  ]
}