{
  "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": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "24 lots; 648 units (multiple units per lot)",
      "code_info": "Product code 900-618,  24 lots:  109010109  109030609  109040846  109051047  109061208  109071536  109071688  109092073  109102337  112020491  112030732  112051999  112062499  112083436  112093647  113036805  113057495  113057617  113078338  113088878  113099446  113109861  140211734  140312178",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "LAPAROSCOPY GYN PACK -    (1) TABLE COVER REINFORCED 44\" X 78\"  (1) LAPAROSCOPY SHEET \"T\" SMS  (3) TOWELS ABSORBENT 15\" X 20\"  (1) SURGICAL BLADE#11 STAINLESS STEEL  (1) MAYO STAND COVER REINFORCED  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK  (2) LEGGINS WITH 7\" CUFF 30\" x 42\"  (1) UNDERBUTTOCK DRAPE WITH POUCH 44\" X 35\"  (4) DRAPE UTILITY WITH TAPE  (2) GOWN IMPERVIOUS REINFORCED LARGE SMS  (1) CONNECTING TUBING 3/16\" X 12\"    EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2337-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}