{
  "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-1491-2021",
      "product_description": "UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach  Material No.M0068318220  Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal.    Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton.   This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.",
      "product_quantity": "8,524 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:  C003726  C003737  C003739  C003752  C003767  C003778  C003782  C003791  C003814  C003818  C003831  C003845  C003846  C003874  C003875  C003898  C003899  C003921  C003942  C003954  C003970  C003988  C003989  C003999  C004000  C004011  C004012  C004031  C004032  C004033  C004048  C004049  C004084  C004085  C004086  C004097  C004098  C004099  C004120  C004132  C004143  C004150  C004159  C004175  C004176  C004196  C004205  C004213  C004218  C004223    GTIN: 08714729848103",
      "more_code_info": ""
    }
  ]
}