{
  "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": "20 lots; 3576 units (multiple units per lot)",
      "code_info": "Product code 900-281, 20 lots:  111061489  112093652  112104098  112114587  112125082  113015512  113015694  113036462  113036731  113057616  113057845  113068168  113078603  113089070  113109824  131110075  131110408  131110585  131210969  140111451",
      "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 -   (I) SURGICAL BLADE #10 S/STEEL   ( I) UTILITY BOWL 32oz  (I) UTILITY BOWL 16oz   (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR  ( I) DRAPE T LAPAROTOMY STD SMS   (2) TOWELS ABSORBENT 15\" x 20\"  (2) GOWN IMP. REINFORCED LARGE SMS   (4) DRAPE UTILITY WITH TAPE  ( I) TABLE COVER REINFORCED 50\" X 90\"   ( I) MAYO STAND COVER REINFORCED  ( I) ELECTRODE DUAL DEPRES./GROUNDPAD   ( I ) CAUTERY PENCIL ROCKER SWITCH  (2) DRAPE SHEET 42\" X 55\" SMS    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-2315-2014",
      "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"
    }
  ]
}