{
  "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": "14 lots; 295 units (multiple units per lot)",
      "code_info": "Product code 900-1402, 14 lots:  112041394  112051751  112072866  112093870  112124944  113036451  113046933  113057834  113088696  113088831  131110172  140111093  140412599  140513083",
      "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": "PLASTIC SURGERY PACK -   LABEL SAMPLE  CONTENTS:  (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF  (10) GAUZE SPONGE 4\" X 4\" 16 PLY LIF (1) TABLE COVER 44\" X 90\"  (1) DRAPE SHEET 70\" X 100\" LIF (2) SURGICAL BLADE #15 S/STEEL  (1) DRAPE HEAD WIT APE 44\" X 26\" LIF (30) COTION TIP APPLIC 6\" WOOD LIF  (1) PVP PAINT 8\" STICK SPONGE  (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F    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-2391-2014",
      "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"
    }
  ]
}