{
  "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": "6 lots (272 packed units, multiple units per lot)",
      "code_info": "900-2615, 6 lots:  113099520  131110253  131210797  140211867  140312138  140412662",
      "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": "Extremity Pack, code 900-2615, contains:  (5) LAP SPONGE PREWASH 18\" X 18\" XRD  (1) ELASTIC BANDAGE WITH VELCRO 4 X 5  (2) BLADE SURGICAL# 15 STAINLES STEEL  (4) DRAPE UTILITY WITH TAPE  (1) GOWN XL SMS IMPERVIOUS REINFORCED  ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP  (1) SKIN MARKER WITH RULER  (1) TUBE SUCTION CONNECT Y4\" X 12'  ( 1) CAST PADDING SOFT ROLL 4\" X 4yds  (10) GAUZE SPONGE 4\" X 4\" 16PLY  ( 1) MERLING SKIN PREP APPLIC 39ML  (1) MAYO STAND COVER REINFORCED  ( 1) TABLE COVER REINFORCED 50\" X 90\"  (2) DRAPE SHEET 42\" X 55\"  ( 1) STOCKINETTE 9\" x 48\"  (1) CAUTERY PENCIL ROCKER SWITCH  (2) LITE GLOVE  ( 1) BANDAGE ESMARK 6\" X 9yds  ( 1) SHEET EXTREMITY ABS SMS 125\" X 85\"  ( 1) UTILITY BOWL QUART 32oz  Product Usage:  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-2480-2014",
      "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"
    }
  ]
}