{
  "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,128 units (multiple units per lot)",
      "code_info": "Code 900-2899, 2 lots  140111333  140412673",
      "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": "CYSTO TUR PACK BASIC   CODE 900-2899.  CONTENTS:\t  (2) LEGGINGS W/7'' CUFF 30\" X 42\"  (1) COVER TABLE REINFORCED 44\" X 78\" (2) TOWELS ABSORBENT 15\" X 20\"  (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill  (1) TUR CYSTO IRRIGATION SET 79\" SINGLE (1) TIME OUT BEACON NON WOVEN ST  (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz  (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER  (1) TURP CYSTO DRAPE WITH POUCH  (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP  Product Usage:  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-2508-2014",
      "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"
    }
  ]
}