{
  "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": "3 lots/567 units (multiple units per lot)",
      "code_info": "Product code 900-2464 ,3 lots  112020343  112051958  112083317",
      "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": "08 PAD PACK II (2,3)  CUSTOMED  CONTENTS:\t  (3) TOWEL ABSORBENT 15\" X 20\" \t(1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED\t (1) SHEET PLASTIC 44\" X 65\" (1) DRAPE UNDERBUTTOCK  W/POUCH \t(1) UMBILICAL CORD CLAMP  (1) BABY BLANKET 30\" X 30\" POLY ABSOR.IMP.\t (1) PACKING VAGINAL XRD 4\" X 36\"  8PLY (10) GAUZE SPONGE  4\" X 4\" 16PLY XRD \t(1) DRAPE ABDOMINAL WITAPE 40\" X 54\"  (2) LEGGINS W/7'' CUFF 30\" X 42\" \t(1) TABLE COVER REINFORCED 44\" X 78\" (2) PAD OBSTETRICAL XL \t(1) EAR ULCER SYRINGE 2oz.    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-2459-2014",
      "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"
    }
  ]
}