{
  "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": "Somerville",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91192",
      "recalling_firm": "Ethicon, Inc.",
      "address_1": "Us Highway 22 West",
      "address_2": "N/A",
      "postal_code": "08876",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International (OUS) only: Canada, Japan, Australia and New Zealand",
      "recall_number": "Z-0480-2023",
      "product_description": "PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1  Product Code: Z340H    For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery",
      "product_quantity": "7,560 eaches",
      "reason_for_recall": "knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage",
      "recall_initiation_date": "20221116",
      "center_classification_date": "20221214",
      "report_date": "20221221",
      "code_info": "UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK  Exp. Date: February 28, 2027"
    }
  ]
}