{
  "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": "2026-07-08",
    "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": "94643",
      "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": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.",
      "recall_number": "Z-2146-2024",
      "product_description": "PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.  PRODUCT CODE:\t\t  D6261\t\t  Z117H\t\t  Z149H\t\t  Z259H\t\t  Z305H\t\t  Z320H",
      "product_quantity": "56952 units",
      "reason_for_recall": "Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .",
      "recall_initiation_date": "20240510",
      "center_classification_date": "20240614",
      "report_date": "20240626",
      "code_info": "GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517    PRODUCT CODE   PRODUCT LOTS                 VCP196H   UBMDDB                 VCP417H   UAMQML                 VCP602H   UAMQQL   UAMSCA              VCP603H   UAMHTC   UAMHZZ        UAMEDC      VCP662H   UBMJSH                 VCPB259H  UAMPKR                 VCPB946H  UAMLJA"
    }
  ]
}