{
  "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": "14 lots; 325 units (multiple units per lot)",
      "code_info": "Product code 900-1742, 14  lots:  111113032  111123382  112010089  112020407  112041202  112051876  112083407  112093915  112125157  113015435  113036757  140412562  140513111  140513393",
      "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": "UROLOGY PACK -      (3) TOWELS ABSORBENT 15\" X 20\" UF   (1) WASH BASIN ROUND 6QT.  (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN   (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX  (1) BAG SUTURE FLORAL   (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP  (1) TABLE COVER 44\" X 90\" UF   (2) DRAPE SHEET 42\" X 55\" SMS UF  (1) TUBE SUCTION CONNECT. Y.\" X 12' UF   (1) MAYO STAND COVER REINFORCED UF  (10) GAUZE SPONGE 4\" X 4\" 16PLY  (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED  (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL   (1) TUR Y SET TWO LEAD ST. UF  (1) DRAPE LITHO 110\" X 63\" SMS WITH LEGGINS    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-2411-2014",
      "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"
    }
  ]
}