{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "44031",
      "product_res_number": "Z-0830-06",
      "event_date_initiated": "2006-01-25",
      "event_date_posted": "2006-05-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-12-21",
      "res_event_number": "34535",
      "product_code": "FFT",
      "product_description": "Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter.  For Gastroesophageal pH Measurements. Catalog number 9012P2121.  Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN  55432-5604, USA.",
      "code_info": "Lot 0001491",
      "firm_fei_number": "1000135098",
      "recalling_firm": "Medtronic Gastroenterology / Urology",
      "address_1": "4000 Lexington Ave N",
      "city": "Shoreview",
      "state": "MN",
      "postal_code": "55126-2917",
      "reason_for_recall": "Lot 0001491 has a manufacturing defect in the sensor spacing.  Sensors have been placed 5 cm apart instead of 15 cm apart.  Medtronic has determined that patient safety is not compromised.  Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.",
      "root_cause_description": "Other",
      "action": "An Urgent Recall letter was issued to all affected customers 1/25/2006.  This letter described the issue and listed what actions customers were to take to return affected product.",
      "product_quantity": "25 individual catheters",
      "distribution_pattern": "within US only:  MI, PA, TX",
      "openfda": {
        "k_number": [
          "K863298",
          "K912772",
          "K811083",
          "K883234",
          "K920849",
          "K903646",
          "K853648",
          "K850074",
          "K910694",
          "K875369",
          "K931963",
          "K874709",
          "K945069",
          "K911825",
          "K850361",
          "K820566",
          "K872929",
          "K850778",
          "K961346",
          "K934434",
          "K822815",
          "K891410",
          "K862727",
          "K871921",
          "K896288",
          "K862536",
          "K013951",
          "K913817",
          "K881706",
          "K913387",
          "K871282",
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          "K102543",
          "K914624",
          "K874710",
          "K841384",
          "K925405",
          "K870606"
        ],
        "device_name": "Electrode, Ph, Stomach",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1400",
        "device_class": "1",
        "registration_number": [
          "3018094310",
          "3016854619",
          "3039167637",
          "9710107",
          "3009106214",
          "3011219572",
          "3007662958",
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        ],
        "fei_number": [
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}