{
  "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": "16 lots; 843 units (multiple units per lot)",
      "code_info": "Product code 900-1688, 16 lots:  112114380  112114643  113036740  113047004  113057426  113068154  113088751  113099276  131110193  140211464  140211704  140311926  140312434  140412555  140513103  140513462",
      "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 CHOLE PACK -   (1) DRAPE LASER CAMERA WITH ELASTIC 6\" X 96\" LIF  (2) SHEET DRAPE 42\" X 57\" SMS  (1) TUBE SUCTION CONNECT. %\" X12' LIF  (1) SURGICAL BLADE #10 STAINLESS STEEL  (1) TABLE COVER REINFORCED 44\" X 78\" LIF  (1) DRAPE LAPAROSC. ABD 102\" X 122\" X 78\" WITH POUCH  (5) LAP SPONGES PREWASH XRD L/F  (1) NEEDLE HYPODERMIC 18G X 1 %\"  (1) MAYO STAND COVER REINFORCED LIF  (1) UTILITY BOWL 32oz. L/F  (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF  (4) TOWEL ABSORBENT 15\" X 20\" L/F  (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (1) CLOTH HUCK TOWEL BLUE L/F  (1) PVP PAINT 8\" STICK SPONGE  (4) DRAPE UTILITY WITH TAPE LIF  (2) UTILITY BOWL 16oz LIF  (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  (1) PVP SCRUB 8\" STICK SPONGES  (1) CLIPS LIGATING TIT M/L (L T 300)  (4) TEGADERM 2 3/8 X 2% L/F  (4) GOWN SURG. 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-2404-2014",
      "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"
    }
  ]
}