{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fort Worth",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97415",
      "recalling_firm": "Alcon Research LLC",
      "address_1": "6201 South Fwy",
      "address_2": "N/A",
      "postal_code": "76134-2099",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI,  and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil,  Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,",
      "recall_number": "Z-0308-2026",
      "product_description": "Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065000356\t27GA HP ENTRY SYSTEM, 4 MM 1 COUNT  8065000358\t25GA HP ENTRY SYSTEM, 6 MM 1 COUNT  8065000359\t27GA HP ENTRY SYSTEM, 6 MM 1 COUNT  8065000467\t25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD  8065000468\t27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD    Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A",
      "product_quantity": "1632",
      "reason_for_recall": "Due to incomplete seals in the pouch which provide the sterile barrier.",
      "recall_initiation_date": "20250805",
      "center_classification_date": "20251024",
      "report_date": "20251105",
      "code_info": "Catalog Number: 8065000356 UDI-DI code: 00380650003560 Lot/Batch Numbers: 17CFND  Catalog Number: 8065000358 UDI-DI code: 00380650003584 Lot/Batch Numbers: 17CMKW 17DR9L  Catalog Number: 8065000359 UDI-DI code: 00380650003591 Lot/Batch Number: 17DWCY  Catalog Number: 8065000467 UDI-DI code: 00380650004673 Lot/Batch Number: 17CP3T  Catalog Number: 8065000468 UDI-DI code: 00380650004680 Lot/Batch Number: 17CP3U"
    }
  ]
}