{
  "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; 1671 units (multiple units per lot)",
      "code_info": "Product code 900-1059, 16 lots:  112030823  113047111  113057410  113057823  113078454  113078566  113099561  113109983  131110149  131110397  131110577  131210955  140211914  140312430  140513062  140513474",
      "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 -   (4) DRAPE UTILITY WITH TAPE LIF  (2) ABSORBENT TOWELS 15\" X 20\" LIF  (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF  (1) SURGICAL DURAPREP SOLUTION 26ml LIF  (1) TUR Y SET 81 \"2.1M REGULAR CLAM ST.  (1) DRAPE LASER CAMERA W/EL 6\" X 96\"  (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F  (1) TABLE COVER 44\" X 90\"  (1) MAYO STAND REINFORCED L/F  (1) SURGICAL BLADE # 11 CARBON STEEL  (1 0) GAUZE SPONGES 4\" X 4\" 16PL Y XRD LIF  (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F  (1) TUBE SUCTION CONNECTING W' X 12' LIF  (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF  (1) CEF AZOLIN RED LABEL  (1) GENTAMICIN GREEN LABEL  (1) AZUL DE METILENO LABEL  (1) HEPARINE WHITE LABEL  (1) LIDOCAINE YELLOW LABEL    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-2369-2014",
      "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"
    }
  ]
}