{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "North Haven",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79154",
      "recalling_firm": "Covidien LLC",
      "address_1": "60 Middletown Ave",
      "address_2": "N/A",
      "postal_code": "06473-3908",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-0640-2018",
      "product_description": "GastriSail\" Gastric Positioning Device  Product Usage:  The GastriSail  gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.",
      "product_quantity": "17,271 units",
      "reason_for_recall": "Reports of gastric or esophageal perforation occurring in procedures where the GastriSail\" Gastric Positioning device has been used.",
      "recall_initiation_date": "20170921",
      "center_classification_date": "20180220",
      "termination_date": "20180926",
      "report_date": "20180228",
      "code_info": "Product numbers:  GPS36 (Pediatric)  GPS40 (Adult)    Lot codes:  E6J0001X  E6J0002X  E6J0003X  E6J0004X  E6J0005X  E6J0006X  E6J0007X  E6J0008X  E6J0009X  E6J0010X  E6J0011X  E6J0012X  E6J0013X  E6J0014X  E6J0015X  E6J0016X  E6J0017X  E6J0018X  E6J0019X  E6J0020X  E6K0001X  E6K0002X  E6K0003X  E6K0004X  E6K0005X  E6K0006X  E6K0007X  E6K0008X  E6K0009X  E6K0010X  E6K0011X  E6K0012X  E6K0013X  E6K0014X  E6K0015X  E6K0016X  E6K0017X  E6K0018X  E6K0019X  E6K0020X  E6K0021X  E6K0022X  E6K0023X  E6K0024X  E6K0025X  E6L0001X  E6L0002X  E6L0003X  E6L0004X  E6L0005X  E6L0006X  E6L0007X  E6L0008X  E6L0009X  E6L0010X  E6L0011X  E6L0012X  E6L0013X  E6L0014X  E6L0015X  E6L0016X  E6L0017X  E6L0018X  E6L0019X  E6L0020X  E6L0021X  E6M0001X  E6M0002X  E6M0003X  E6M0004X  E6M0005X  E6M0006X  E6M0007X  E6M0008X  E6M0009X  E6M0010X  E6M0011X  E6M0012X  E6M0013X  E6M0014X  E7A0001X  E7A0002X  E7A0003X  E7A0004X  E7A0005X  E7A0006X  E7A0007X  E7A0008X  E7A0009X  E7A0010X  E7A0011X  E7A0012X  E7A0013X  E7A0014X  E7A0015X  E7A0016X  E7A0017X  E7A0018X  E7A0019X  E7B0001X  E7B0002X  E7B0003X  E7B0004X  E7B0005X  E7B0006X  E7B0007X  E7B0008X  E7B0009X  E7B0010X  E7B0011X  E7B0012X  E7B0013X  E7B0014X  E7B0015X  E7C0001X  E7C0002X  E7D0001X  E7D0002X  E7D0003X  E7D0004X  E7D0005X  E7D0006X  E7D0007X  E7D0008X  E7D0009X  E7D0010X  E7E0001X  E7E0002X  E7E0003X"
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