{
  "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": "10 lots (2018 packaged units, multiple units per lot)",
      "code_info": "Product code 900-2511, 10 lots:  112083072  113099519  113109796  131110292  131210659  140111323  140211706  140211936  140412903  140513479",
      "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": "Minor Pack  900-2511, pack contains:  (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD  (5) LAP SPONGE PREWASH 18\" X 18\" XRD  (1) DRAPE LAPAROTOMY W/POUCH 100\" x 72\" x 124\"  (4) DRAPE UTILITY WITH TAPE  (2) DRAPE SHEET 41\" X 69\" MEDIUM  ( 1) MAYO STAND COVER REINFORCED  ( 1) GOWN SURG XLGE REINFORCED TOWEL & WRAP AAMIIII  ( 1) BLADE SURGICAL STAINLESS STEEL# 10  (2) LIGHT SHIELD  ( 1) CAUTERY PENCIL ROCKER SWITCH  ( 1) TABLE COVER REINFORCED 50\" X 90\"  ( 1) UTILITY BOWL BLUE 16oz  ( 1) TOWELS ABSORBENT 15\" X 20\"  ( 1) SOLUTION SURGICAL DURAPREP 6ML  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-2475-2014",
      "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"
    }
  ]
}