{
  "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": [
    {
      "country": "United States",
      "city": "Plymouth",
      "address_1": "4600 Nathan Ln N",
      "reason_for_recall": "Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.",
      "address_2": "",
      "product_quantity": "154,152 units",
      "code_info": "Model Number SP-101:  GTIN 20643169986279, Serial Numbers:  54143, 54145, 54146, 54147, 54148, 54149, 54150, 54151, 54152, 54396, 54397, 54398, 54399, 54417, 54418, 54419, 54420, 54618, 54619, 54620, 54621, 54622, 54771, 54772, 54773, 54774, 54775, 54776, 54794, 54795, 54796, 54924, 54925, 54926, 54927, 54928, 54929, 55027, 55028, 55029, 55030, 55031, 55032, 55068, 55069, 55070, 55071, 55072, 55073, 55113, 55114, 55115, 55116, 55437, 55438, 55439, 55440, 55441, 55442, 55483, 55484, 55485, 55486, 55487, 55488, 55594, 55595, 55596, 55597, 55598, 55599, 55675, 55676, 55677, 55678, 55683, 55684, 55775, 55776, 55777, 55778, 55790, 55791, 55792, 55793, 55794, 55852, 55853, 55854, 55855, 55856, 55948, 55949, 55951, 55952, 55953, 55991, 55992, 55993, 55994, 55995, 56109, 56110, 56111, 56123, 56159, 56160, 56161, 56162, 56163, 56189, 56193, 56195, 56196, 56216, 56218, 56219, 56387, 56388, 56389, 56391, 56464, 56465, 56466, 56467, 56468, 56528, 56529, 56530, 56531, 56532, 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56199, 56200, 56202, 56384, 56469, 56470, 56473    Model Number VS-404:  GTIN 00643169437975, Serial Numbers:  61677  GTIN 00673978070469, Serial Numbers:  62015  GTIN 00673978070872, Serial Numbers:  62006  GTIN 00763000240776, Serial Numbers:  61475, 61673, 61674, 61678, 61696, 61933, 61934, 61938, 61939, 61940, 61941, 61943, 61947, 62013, 62022  GTIN 00763000279769, Serial Numbers:  61675    Please note that VS-403 is not approved in the U.S. and has not been distributed outside of the United States; the scope of this corrective action will include this product as it is launched in OUS regions beginning Summer 2021.",
      "center_classification_date": "20210512",
      "distribution_pattern": "Distributed nationwide to MA, NY, VT, NH, ME",
      "state": "MN",
      "product_description": "VenaSeal Closure System",
      "report_date": "20210519",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Medtronic Inc.",
      "recall_number": "Z-1564-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "87619",
      "more_code_info": "",
      "recall_initiation_date": "20210323",
      "postal_code": "55442-2890",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}