{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86004",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "address_2": "",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "World wide distribution.",
      "recall_number": "Z-2761-2020",
      "product_description": "Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can  be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide\" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.",
      "product_quantity": "",
      "reason_for_recall": "BSC has noted a potential inability to cut and  remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.",
      "recall_initiation_date": "20200706",
      "center_classification_date": "20200805",
      "report_date": "20200812",
      "code_info": "Outer Package UPN #: M00562321  Inner Package UPN #: M00562320  GTIN: 08714729019336  Lot #s: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, 25513671  Expiration Dates: 4-Feb-23 through 14-May-23",
      "more_code_info": ""
    }
  ]
}