{
  "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": "2 lots; 258 units (multiple units per lot)",
      "code_info": "Product code 900-1295, 2 lots:  111030561  112031009",
      "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": "PREMIUM UROLOGY PACK - CUSTOMED-     (1) LITHOTOMY DRAPE W/POUCH ANESTH.  (2) ABSORBENT TOWELS UF  (1) MAYO STAND COVER REINFORCED UF  (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF  (1) GOWN SURG. REINFORCED LARGE T/WRAP  (1) UTILITY BOWL 32 OZ.  (1) TUBE SUCTION CONNEC. W' X 12' UF  (1) TABLE COVER REINFORCED 50\" X 90\" UF  (1) TUR Y SET 81 \"2.1M REGULAR CLAM ST.  (1) GOWN XL SMS IMPERVIOUS REINFORCED  (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL    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-2383-2014",
      "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"
    }
  ]
}