{
  "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; 148 units (multiple units per lot)",
      "code_info": "Product code 900-1515, 2 lots:  110061486  111030825",
      "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 CHOLECYSTECTOMY PACK-   (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY XRD UF  (2) ABSORBENT TOWELS 15\" X 20\" UF  (1) MAYO STAND COVER REINFORCED UF  (4) BANDAGE ADHESIVE W' x 3\" L I F  (4) DRAPE UTILITY WIT APE UF  (1) TUBE SUCTION CONNECT. Y..'' X 12' UF  (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF  (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF  (1) IMP. GOWN REINFORCED XLge. SMS  (2) SYRINGE 60ML W/0 NDL. LILOCK UF  (1) SYRNGE 20 cc W/0 NDL ULOCK UF  (1) SURGICAL BLADE #15 C/STEEL  (1) DRAPE LASER CAMERA W/EL  (2) COVER HANDLE LITE LOCK  (1) TABLE COVER Reinforced 50\" x 90\" UF  (3) DRAPE SHEET 41 \" x 58\" SMS  (1) SURG. GOWN REINFORCED T/Wrap Lge.    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-2399-2014",
      "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"
    }
  ]
}