{
  "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": "11 lots; 540 units (multiple units per lot)",
      "code_info": "Product code 900-982, 11 lots:  112093957  112114688  112125123  113025981  113067944  113078479  113088900  113109884  131110285  140111261  140412707",
      "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": "ARHTROSCOPY PACK-   (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT  (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE  (1) TOWEL ABSORBENT 15\" X 20\"  (1) MAYO STAND COVER REINFORCED  (1) TABLE COVER REINFORCED 50\" X 90\"  (1) BAG SUTURE FLORAL  (1) STOCKINETTE IMPERVIOUS 14\" X 48\"  (4) STRIPS TAPE 24\" X 4\"  (1) SHEET EXTREMITY ABS. 125\" X 85\"  (1) TIME OUT BEACON NON WOVEN ST.    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-2363-2014",
      "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"
    }
  ]
}