{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Santa Clara",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94541",
      "recalling_firm": "Covidien, LLC",
      "address_1": "3062 Bunker Hill Ln",
      "address_2": "N/A",
      "postal_code": "95054-1105",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, \tFL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, \tUT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, \tDenmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.",
      "recall_number": "Z-2038-2024",
      "product_description": "EsoFLIP,  30mm BALLOON DILATION CATHETER, REF ES-330,  Rx Only",
      "product_quantity": "N/A",
      "reason_for_recall": "Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements  that may lead to various harms.",
      "recall_initiation_date": "20240425",
      "center_classification_date": "20240607",
      "report_date": "20240619",
      "code_info": "GTIN Number: 10884521809451/ Lot: 22K0854JZ, 23H0552JZ;  GTIN Number: 20884521809458/ Lot:  22E0781JZ, 22E0997JZ, 22I0422JZ, 22I0424JZ, 22I0425JZ, 22J1362JZ,22K0743JZ, 22K0744JZ, 22K0745JZ,22K0746JZ, 22K0854JZ, 23A0109JZ,23A0111JZ, 23A1200JZ, 23A1201JZ,23A1202JZ, 23C0144JZ, 23C0668JZ, 23C0669JZ, 23D0777JZ, 23D0778JZ,23H0047JZ, 23H0552JZ, 23H0553JZ,23H0554JZ, 23H0623JZ, 23H0624JZ,23L0331JZ, 23L0338JZ, 23L0339JZ,24A0014JZ, 24A0015JZ, 24B0392JZ"
    }
  ]
}