{
  "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": "Temple Terrace",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93656",
      "recalling_firm": "American Contract Systems, Inc.",
      "address_1": "7802 E Telecom Pkwy",
      "address_2": "",
      "postal_code": "33637-0928",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0823-2024",
      "product_description": "Custom procedural convenience kits and trays, urological, labeled as:    a) UROLOGY DAVINCI PACK, kit number HGUR87G;   b) CYSTO PACK, kit number LVCY20;   c) URO ROBOTIC PACK, kit number LVUR44;",
      "product_quantity": "1031 units",
      "reason_for_recall": "During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the  piggybacked  components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.",
      "recall_initiation_date": "20231129",
      "center_classification_date": "20240126",
      "report_date": "20240207",
      "code_info": "a) HGUR87G, UDI/DI none, Lot Numbers:  751221, exp. 9/6/2023; 651221, exp. 12/15/2023; 973231, exp. 1/27/2024; 939231, exp. 3/2/2024;  b) LVCY20, UDI/DI 00191072117991, Lot Numbers:  769221, exp. 8/19/2024; 727221, exp. 9/30/2024; 701221, exp. 10/26/2023; 643221, exp. 12/23/2023; 912231, exp. 3/29/2024;  c) LVUR44, UDI/DI 00191072136688, Lot Numbers:  846221, exp. 6/3/2023; 938231, exp. 3/3/2024",
      "more_code_info": ""
    }
  ]
}