{
  "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": "Raritan",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92084",
      "recalling_firm": "Ethicon, Inc.",
      "address_1": "1000 Route 202",
      "address_2": "N/A",
      "postal_code": "08869-1425",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution in the countries of United Kingdom, Ireland and Turkey.",
      "recall_number": "Z-1571-2023",
      "product_description": "PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue.  Product Code: PDP9625H",
      "product_quantity": "1,656 eaches (OUS only)",
      "reason_for_recall": "Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved",
      "recall_initiation_date": "20230331",
      "center_classification_date": "20230510",
      "report_date": "20230517",
      "code_info": "UDI-DI: (01)10705031124691 Primary (Individual Unit);               (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH"
    }
  ]
}