{
  "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": "49 lots; 1804 units (multiple units per lot)",
      "code_info": "Product code 900-1717, 49 lots:  109102292  109112479  109122763  110030824  110040903  110061439  110071672  110081970  110082178  110092389  110112617  110122925  111010065  111020275  111030600  111051279  111061510  111071778  111082063  111092363  111102698  111113030  111123378  112010085  112020403  112030641  112041198  112051872  112062446  112072784  112083404  112093911  112104294  112114647  112125031  113036755  113057397  113067893  113078272  113088758  113089199  113099389  131110197  131210759  140111170  140312083  140412457  140513109  140613626",
      "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": "O.B. PACK -   (I) TABLE COVER REINFORCED 50\" X 90\" LIF  (I) DRAPE UNDERBUTTOCK WITH POUCH 44\" X 35\"  (2) LEGGINS W/7'' CUFF 30\" X 42\"  (1) GOWN LARGE SMS IMPERVIOUS REINFORCED  (3) TOWELS ABSORBENT 15\" X 20\" LIF  (I) PAD OBSTETRICAL X-LARGE ST.  (I) PACKING VAG JNAL 4\" X 36\" 8PL Y XRD  (10) GAUZE SPONGES 4\" X 4\" 12PLY XRD  (I) UMBILICAL CORD CLAMP  (1) BABY BLANKET PRINTED  (2) EAR/ULCER SYRINGE 2oz. LIF  (I) COVER SET UP 42\" X 75\" CLEARPOLY  (1) DRAPE ABDOMINAL WITH TAPE L/F  (1) BOWL WITH LID PLASTICS 80oz. L/F  (1) SHEET DRAPE 41\" X 58\" SMS LIF    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-2407-2014",
      "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"
    }
  ]
}