{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65314",
      "recalling_firm": "Coloplast Manufacturing US, LLC",
      "address_1": "1601 W River Rd",
      "address_2": "N/A",
      "postal_code": "55411-3431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to: KY, MI, OH, PR, TX, and VA.",
      "recall_number": "Z-1486-2013",
      "product_description": "Digitex Absorbable Polydiaxanone Suture, Size 2-0.   Catalog Number / Code of product: 52031, 5203101400.    The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.",
      "product_quantity": "772 units",
      "reason_for_recall": "Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.",
      "recall_initiation_date": "20130513",
      "center_classification_date": "20130605",
      "termination_date": "20140410",
      "report_date": "20130612",
      "code_info": "Lots 3390331, 3390339, 3390490."
    }
  ]
}