{
  "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": "25 lots; 552 units (multiple units per lot)",
      "code_info": "Product code 900-484, 25  lots:  110112811  110123129  111010130  111030679  111040976  111051201  111071818  111082100  111092392  111092547  111123258  112020476  112041331  112072873  112083432  112093945  113026060  113026073  113036489  113036802  113067928  113088868  113109845  131210819  140211845",
      "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": "LAPAROSCOPY~OBPACK -   (4) ABSORBENT TOWELS 15\" x 20\" LIF  (2) LEGGINS WITH 7\" CUFF  (1) LAPAROSCOPY T SHEET SMS  (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  (1) NEEDLE HYPODERMIC 18G X 1%  (1) *ROBIN REDRUBBER CATHETER 14FR LATEX  (1) DRAPE LASER CAMERA W/EL LIF  (1) PAD OBSTETRICAL X-LARGE 6\" X 96\" LIF  (3) TOWEL CLAMP  (4) DRAPE UTILITY WITH TAPE LIF  (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV  (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV  (20) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (1) TABLE COVER 44\" X 90\"  (1) MAYO STAND COVER REINFORCED LIF  (1) SURGICAL BLADE #15 CARBON STEEL  (1) LITE GLOVE LIF  (1) DRESSING NON-ADHESIVE TELFA 4\" X 3\"  (1) TUBE SUCTION CONNECT Y4\" X 12' 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-2328-2014",
      "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"
    }
  ]
}