{
  "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; 1521 units (multiple units per lot)",
      "code_info": "Product code 900-1460, 29 lots:  109050945  111123344  112010046  112020337  112041074  112051759  112062229  112062272  112083031  112083391  112093722  112114564  112124948  113015428  113036592  113047001  113047147  113057686  113067887  113078253  113078702  113089190  131110174  131210632  140111081  140211866  140311920  140312391  140513089",
      "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": "REYITO UROLOGY PACK -   (2) GOWN IMP. REINFORCED X-LARGE SMS   (2) TOWELS ABSORBENT UF  ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF   ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF  ( I) BAG SUTURE   (I) TABLE COVER  ( I} TUBE SUCTION CONNECT. W' X 12' UF   (10) GAUZE SPONGES 4\" X 4\" 16PLY  ( I) EMESIS BASIN   (I) DRAPE LASER CAMERA W/E  ( I} UTILITY BOWL32oz   (I) BOWL PLASTIC 80oz WITH LID  ( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF   (I} SYRINGE IOcc PREFILLED WITH GEL  (5) CONTAINER SPECIMEN 4oz W/LID & LABEL   (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE  ( I} TUR Y SET, 2LEAD UF   ( I} DRAPE LITHO 11 0\" X 63\" WI POUCH WILEGGING  ( I} ROUND WASH BASIN 6QT.    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-2393-2014",
      "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"
    }
  ]
}