{
  "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": "15 lots; 860 units (multiple units per lot)",
      "code_info": "Product code 900-1298, 15 lots:  112041185  112062555  112072865  113015632  113026067  113026165  113026272  113036748  113047122  113057832  113078568  113089184  113109720  140111149  140211639",
      "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": "PREMIUM ARTHROSCOPY PACK - CUSTOMED-     (1) ARTHROSCOPY SHEET T WITH POUCH LIF  (1) IMPERVIOUS STOCKINETTE  (3) STRIPS TAPE 24\" X 4\"  (1) DRAPE U WITH TAPE SPLIT  (2) TOWELS ABSORBENT 15\" X 20\" LIF  (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS  (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) MAYO STAND COVER REINFORCED LIF  (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (1) TUBE SUCTION CONNECT. }4\" X 12' LIF  (1) SURGICAL BLADE #11 CARBON STEEL  (1 ELASTIC BANDAGE 6\" X 5 YRD. 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-2386-2014",
      "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"
    }
  ]
}