{
  "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": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95946",
      "recalling_firm": "Sklar Instruments",
      "address_1": "1333 Lenape Rd",
      "address_2": "",
      "postal_code": "19382-6816",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: Nationwide Distribution",
      "recall_number": "Z-0944-2025",
      "product_description": "ECONO STERILE medical procedure kits labeled as:      1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603;   2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605;   3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607;   4) ECONO STERILE PEDERSON SPEC STERILE\" SM BX/25, Model Number 96-2613;   5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615;   6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616;   7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617;   8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001;   9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological",
      "product_quantity": "475 units",
      "reason_for_recall": "Reports of various packaging issues that may result in a breach of the sterile barrier.",
      "recall_initiation_date": "20241203",
      "center_classification_date": "20250116",
      "report_date": "20250122",
      "code_info": "1) 96-2603, UDI/DI 50649111067233, Lot Codes:  SK-119;  2) 96-2605, UDI/DI 50649111067622, Lot Codes:  SK-119;  3) 96-2607, UDI/DI 50649111067967, Lot Codes:  SK-119;  4) 96-2613, UDI/DI 50649111068964, Lot Codes:  SK-119;  5) 96-2615, UDI/DI 50649111069343, Lot Codes:  SK-119;  6) 96-2616, UDI/DI 50649111069572, Lot Codes:  SK-119;  7) 96-2617, UDI/DI 50649111069886, Lot Codes:  SK-119;  8) 96-3001, UDI/DI 50649111133884, Lot Codes:  SK-119;  9) 96-3002, UDI/DI 50649111134058, Lot Codes:  SK-119.",
      "more_code_info": ""
    }
  ]
}