{
  "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": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87709",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan,  Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia,  Netherlands, New Zealand, Norway, Panama, Poland, Portugal,  Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain,  Sweden, Switzerland, Taiwan.",
      "recall_number": "Z-1490-2021",
      "product_description": "Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure.    Material No. M0068318210",
      "product_quantity": "4,549 WW",
      "reason_for_recall": "Potential for pinholes (sterile barrier breach)  on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection",
      "recall_initiation_date": "20210415",
      "center_classification_date": "20210423",
      "report_date": "20210505",
      "code_info": "All unexpired lots:  C003699  C003715  C003735  C003750  C003775  C003804  C003813  C003842  C003853  C003887  C003905  C003936  C003950  C003960  C003966  C003986  C003997  C004028  C004041  C004078  C004091  C004107  C004117  C004128  C004136  C004160  C004186  C004206  C004221    GTIN 08714729848097",
      "more_code_info": ""
    }
  ]
}