{
  "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": "2 lots/ 18 units, multiple units per lot",
      "code_info": "900-3113, 2 lots:  131110435  131210803",
      "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": "General Cosmetic Pack FCSC, Code 900-3113, contains:  (1) COVER MAYO STAND REINFORCED LIF  (10) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (2) GOWN LARGE STANDARD SMS AAMIIII  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) TOWEL ABSORBENT 15\" X 20\" LIF  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (1) SYRINGE BULB 60CC LIF  (1) BLADE SURGICAL #15 CARBON STEEL  (1) NEEDLE HYPODERMIC 18G X 1% LIF  (6) TOWEL CLOTH HUCK BLUE LIF  (4) DRAPE UTILITY WITH TAPE L/F  (1) NEEDLE HYPODERMIC 25 X 1% L/F  (1) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK LIF  (2) SYRINGE 10CC WITHOUT NNEDEL LUER LOCK LIF  (2) NEEDLE SPINAL ANESHT 20G X 3%\" LIF  (1) SKIN MARKER WITH RULER LIF  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F  (1) LITE GLOVE  (1) DRAPE BREAST/CHEST SMS LIF  (1) TUBE SUCTION CONNECT%\" X 12' LIF  (10) GAUZE SPONGE 4\" X 4\" 16PLY L/F  (2) GLOVE MEDIUM FREETOOUCH VYNIL POWDER FREE  (1) TRAY 3/COMPARTMENT  (1) WRAPPER 24\" X 24\" L/F  (2) PK. SURG. GLOVE# 7% ENCORE POWDER FREE LATEX  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-2523-2014",
      "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"
    }
  ]
}