{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allen",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85389",
      "recalling_firm": "Quest Medical, Inc.",
      "address_1": "1 Allentown Pkwy",
      "address_2": "N/A",
      "postal_code": "75002-4206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution including in the states of  NY, PA, TN, WV. OUS:  None",
      "recall_number": "Z-2107-2020",
      "product_description": "Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI:  (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135  (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)",
      "product_quantity": "5 units",
      "reason_for_recall": "Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed.  This could lead to over delivery of potassium by the user requiring medical intervention.",
      "recall_initiation_date": "20191217",
      "center_classification_date": "20200522",
      "termination_date": "20240417",
      "report_date": "20200603",
      "code_info": "Lot Number: 059135"
    }
  ]
}