{
  "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": "38 lots; 2442 units (multiple units per lot)",
      "code_info": "Product code 900-345, 38 lots:  109122917  110020470  110030770  110040936  110071690  110092240  110112640  111010116  111030655  111051294  111051326  111071845  111082215  111092537  111102740  111113101  111123239  112010162  112030866  112051977  112093937  112104306  112124703  112124858  113025959  113036353  113046956  113067922  113088810  113089162  113109830  131210950  140211466  140312155  140412559  140513144  140513338  140613746",
      "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": "BASIC PACK W/OUT GOWN-  (1) TABLE COVER REINFORCED 50\" X 90\" UF  (4) DRAPE UTILITY WITH TAPE UF  (1) TOWEL ABSORBENT 15\" x 20\" L/F  (1) SUTURE BAG FLORAL  (1) DRAPE SHEET 42\" X 57\" SMS  g~ SHEET o/. 57\" X 63\" REINFORCED SMS UF  MAYO STAND COVER REINFORCED UF    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-2317-2014",
      "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"
    }
  ]
}