{
  "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": "48 lots; 15008 units (multiple units per lot)",
      "code_info": "Product code 900-176, 48 lots:  110030643  110040905  110081992  111020467  111020499  111030609  111030830  111030932  111051336  111051472  111061512  111071910  111072024  111082068  111092366  111092455  111102645  111112937  111113036  111113163  111123386  111123476  112010091  112010247  112010272  112010285  112020410  112020565  112020570  112030693  112030890  112031006  112041370  112051553  112051879  112062449  112062566  112083377  113099568  131110070  131110404  131110581  131210965  140111413  140211741  140312333  140412794  140513112",
      "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": "LAPAROTOMY PACK - CUSTOMED-   (1) BAG SUTURE FLORAL  (2) TOWEL ABSORBENT 15\" X 20\"  (1) MAYO STAND COVER REINFORCED  (1) DRAPE T LAPAROTOMY STD SMS  (2) SHEET DRAPE 42\" X 57\"  (1) TABLE COVER REINFORCED 50\" X 90\"  (4) DRAPE UTILITY WITH TAPE    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-2312-2014",
      "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"
    }
  ]
}