{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "205087",
      "product_res_number": "Z-0722-2024",
      "event_date_initiated": "2023-12-07",
      "event_date_posted": "2024-01-12",
      "recall_status": "Open, Classified",
      "res_event_number": "93673",
      "product_code": "MQG",
      "product_description": "MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429",
      "code_info": "UDI-DI 00827002444294\n\nLots AM109365\nAM109363\nAM109356\nAM111934\nAM111932\nAM111933\nAM112041\nAM112042\nAM112039\nAM112040\nAM112043\nAM112071\nAM112072\nAM112316",
      "firm_fei_number": "3007965706",
      "recalling_firm": "Cook Medical Llc",
      "address_1": "1025 W Acuff Rd",
      "city": "Bloomington",
      "state": "IN",
      "postal_code": "47404-9295",
      "reason_for_recall": "The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.",
      "root_cause_description": "Device Design",
      "action": "The firm notified affected customers on December 7, 2023 via URGENT Medical Device Correction letters.\n\nPer the letter, customers can continue to use their MINC+ device whilst awaiting the defect correction, but Cook advises customers to be vigilant and monitor for device alerts. If the device produces audible and visual alerts to indicate an error with temperature, customers must immediately move any dishes to another incubator. If no other incubators are available, the device can be reset to normal operation by switching off mains power to the device for ten seconds then turning the power back on. The software/firmware update will undergo\nverification testing including compliance testing prior to release. The updated\nsoftware/firmware is expected to be available on 01 February 2024.\n\nAn authorized service agent will contact customers to arrange for the device to\nbe corrected at their facility. The service agent will be updating the\nsoftware/firmware of the device.",
      "product_quantity": "14 US; 101 OUS",
      "distribution_pattern": "Domestic distribution to CA\nIN\nLA\nMD\nNY\n\n\nInternational distribution to AUSTRALIA\nAUSTRIA\nSPAIN\nFINLAND\nFRANCE\nINDIA\nIRELAND\nITALY\nKUWAIT\nSWITZERLAND\nTURKEY\nUNITED KINGDOM",
      "openfda": {
        "k_number": [
          "K132870",
          "K160753",
          "K030525",
          "K991216",
          "K121566",
          "K000394",
          "K013401",
          "K014160",
          "K021042",
          "K242684",
          "K002805",
          "K011327",
          "K002961",
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          "K260194",
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          "K180304",
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          "K133712",
          "K041952",
          "K001486",
          "K983642",
          "K032526",
          "K991263",
          "K001524",
          "K173264",
          "K001600",
          "K991408",
          "K992070",
          "K002971",
          "K092183",
          "K180188",
          "K133742",
          "K111715",
          "K023465",
          "K232493",
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          "K003184",
          "K002595",
          "K032086",
          "K113075",
          "K160504",
          "K983609",
          "K171736",
          "K020560"
        ],
        "registration_number": [
          "1221433",
          "3017247483",
          "3009747883",
          "1825146",
          "3005580113",
          "3006405073",
          "3004871219",
          "3003244268",
          "9680654",
          "3009107689",
          "3023235140",
          "3034431159",
          "9610632",
          "3008157119",
          "1066270",
          "9613662",
          "3003775072",
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        ],
        "fei_number": [
          "1221433",
          "3017247483",
          "3005737891",
          "3003751666",
          "3009747883",
          "1825146",
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          "3002919051",
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          "3003775072",
          "1000120774",
          "1523845",
          "3000957797",
          "1216677",
          "1000393132",
          "3007530363",
          "1820334",
          "3012853704",
          "3031594904"
        ],
        "device_name": "Accessory, Assisted Reproduction",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6120",
        "device_class": "2"
      }
    }
  ]
}