{
  "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": "34 lots; 1136 units (multiple units per lot)",
      "code_info": "Product code 900-605,  34 lots:  110092266  110102447  110112666  110123109  111010142  111020291  111030694  111040908  111061557  111071939  111082104  111092395  111102768  111113129  111123270  112010189  112020490  112030886  112051997  112062497  112072807  112083435  112093728  112124593  112125104  113078336  113088877  113099445  113109859  131110267  131210832  140111091  140312177  140412696",
      "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 GYN PACK -  -   (1) BLADE SURGICAL #11 STAINLESS STEEL  (4) DRAPE UTILITY WITH TAPE LIF  (2) ABSORBENT TOWEL 15\" X 20\" LIF  (1) GOWN IMPERVIOUS REINFORCED LARGE SMS  (1) TOWEL CLOTH HUCK BLUE  (1) BLADE SURGICAL #15 CARBON STEEL  (2) UTILITY BOWL 16oz  (1) UTILITY BOWL 32oz  (2) LEGGINS WITH 7\" CUFF 30\" X 42\" LIF  (1) EMESIS BASIN 10in 700cc  (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF  (1) MAYO STAND COVER REINFORCED LIF  (10) GAUZE SPONGES 4\" X 4\" 16PLY XRD LIF  (2) TUBE SUCTION CONNECT 114\" X 12' LIF  (1) TABLE COVER REINFORCED 44\" X 78\" UF  (1) DRAPE LAP. PERINEAL 102\" X 97\" WITH POUCH  (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP    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-2335-2014",
      "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"
    }
  ]
}