{
  "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": "43297",
      "product_res_number": "Z-0359-06",
      "event_date_initiated": "2005-12-13",
      "event_date_posted": "2006-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-05-15",
      "res_event_number": "34222",
      "product_code": "FAP",
      "k_numbers": [
        "K931175"
      ],
      "product_description": "Replacement balloons for use with Sandhill Anorectal Manometry Probes.  There is no labeling other than the part number for these products.",
      "code_info": "All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.",
      "firm_fei_number": "2023374",
      "recalling_firm": "Sandhill Scientific, Inc",
      "address_1": "9150 Commerce Center Cir Ste 500 9150 Commerce Center Cir",
      "address_2": "Ste 500",
      "city": "Highlands Ranch",
      "state": "CO",
      "postal_code": "80129-1563",
      "additional_info_contact": "Guy Harris\n303-470-7020",
      "reason_for_recall": "Labeling does not indicate that the product contains latex.",
      "root_cause_description": "Other",
      "action": "All consignees were notified by letter on 12/3/05.  Canadian consignees were re-notified on December 14, 2005 by letter.",
      "product_quantity": "2358 Probes",
      "distribution_pattern": "Distributed nationwide including PR.  Military distibution in MD and TX.  Veteran Affairs facilities located in AR, CO, CT, HI, and NC.  Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.",
      "openfda": {
        "k_number": [
          "K852856",
          "K792093",
          "K863165",
          "K920451",
          "K850695",
          "K792092",
          "K823432",
          "K920777",
          "K931175",
          "K920575",
          "K963330",
          "K822916",
          "K844503",
          "K863312",
          "K922476",
          "K913169",
          "K912701",
          "K920992",
          "K851483",
          "K914891",
          "K833628",
          "K790519",
          "K910371",
          "K850696",
          "K863168",
          "K931179",
          "K850694",
          "K770579",
          "K800822",
          "K850693",
          "K850601",
          "K901494",
          "K913736",
          "K915484",
          "K820144",
          "K874759",
          "K771850",
          "K902692",
          "K924383",
          "K921047",
          "K853059",
          "K896575",
          "K870855",
          "K853936",
          "K790478",
          "K962472",
          "K924086",
          "K910217",
          "K910285",
          "K914300",
          "K923464",
          "K923995",
          "K821939",
          "K834503",
          "K113771",
          "K974775",
          "K884915",
          "K913323",
          "K915443",
          "K790754",
          "K862327",
          "K904646",
          "K863167",
          "K902843",
          "K823561",
          "K920991",
          "K853683",
          "K910444",
          "K912451",
          "K881736",
          "K842124",
          "K884920",
          "K863169",
          "K792090",
          "K850602",
          "K792094",
          "K874758",
          "K860571",
          "K792091",
          "K812178",
          "K904386",
          "K802374",
          "K911091",
          "K900494",
          "K911125"
        ],
        "device_name": "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1620",
        "device_class": "2",
        "registration_number": [
          "3006849754",
          "3011534533",
          "3011137372",
          "1825146",
          "2132111",
          "1930870",
          "3004365956",
          "1820334",
          "3000296634"
        ],
        "fei_number": [
          "3006849754",
          "3011534533",
          "1825146",
          "3005747797",
          "1930870",
          "3004365956",
          "1000140026",
          "1820334",
          "3000296634"
        ]
      }
    }
  ]
}