{
  "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": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "61253",
      "recalling_firm": "American Optisurgical Inc",
      "address_1": "26902 Vista Ter",
      "address_2": "N/A",
      "postal_code": "92630-8123",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution: MN only.",
      "recall_number": "Z-1817-2012",
      "product_description": "TX1 Tissue Removal System Console. Model: TX1  TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections.    Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.",
      "product_quantity": "5units",
      "reason_for_recall": "Two reasons for recall.    1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health.     2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.",
      "recall_initiation_date": "20120222",
      "center_classification_date": "20120615",
      "termination_date": "20120615",
      "report_date": "20120627",
      "code_info": "Product Codes: LFL, GEI,   Serial #: 55400001, 55400002, 55400003.  Part Order No: 554-0034-000  510(K) Mp.: K101561"
    }
  ]
}