{
  "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": "25 lots/ 493 units",
      "code_info": "900-1196C, 25 lots:  109081948  111020513  111040952  111041136  111051468  111112924  111113162  112010244  112020547  112020554  112051555  112062220  112082996  112083217  112093966  112114785  113015636  113036439  113078353  113109656  131210739  140111446  140312370  140513169  140613799",
      "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": "Open Heart Tray, Pack A, code 900-1196C, contains:  (1) TABLE COVER REINFORCED L/Free  (1) CARDIOVASCU.LAR INCISE DRAPE L/Free  (2) 3/4 ABS. REINFORCED SHEET  (1) PLASTIC SHEET  (5) DRAPE SHEET SMS  (18) CLOTH HUCK TOWELS Blue  (4) CLOTH HUCK TOWELS White  (1 0) ABSORBENT TOWELS L/Free  (4) GOWN IMP. BREATHABLE LGE.  (3) MAYO STAND COVER L/Free  (2) IMPERV. STOCKINETTE  (1) WRAPPER 54\" X 54\"  (1) TRAY PLATFORM LGE  (1) TABLE COVER HD L/Free  (1) WRAPPER 24\" X 24\"  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-2531-2014",
      "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"
    }
  ]
}