{
  "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": "29 lots/2675 units, (multiple units per lot)",
      "code_info": "Product code 900-2167, 29 lots  111041037  111051291  111061531  111102864  112010130  112020462  112030812  112041223  112051942  112062480  112072798  112083163  112083421  112093927  113057460  113067915  113078469  113088789  113089024  113109643  113109789  131110238  131210786  140111203  140312119  140412646  140513126  140513397  140613659",
      "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": "LITHOTOMY PACK   CONTENTS:\t  (2) \tTOWELS ABSORBENT 15\" X 20\"  (2) \tLEGGINGS W/7'' CUFF 30\" X 42\" CSR  (1) DRAPE UNDERBUTTOCK WITH POUCH 44\" x 35\"  (1) DRAPE ABDOMINAL WITH TAPE  40\" X 54\"  (1) DRAPE UTILITY WITH TAPE  (1) TABLE COVER REINFORCED 50\" X 90\"  (1) TIME OUT BEACON NON WOVEN ST.      Product Usage:  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-2437-2014",
      "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"
    }
  ]
}