{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Blue Ash",
      "address_1": "4545 Creek Rd",
      "reason_for_recall": "Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired",
      "address_2": "",
      "product_quantity": "480 units",
      "code_info": "Lot Codes: P9461W, P94K20",
      "center_classification_date": "20190108",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON  MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN  URUGUAY and VIETNAM.",
      "state": "OH",
      "product_description": "PROXIMATE¿ HCS Hemorrhoidal Circular Stapler  Product Code: PPH01     PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.",
      "report_date": "20190116",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ethicon Endo-Surgery Inc",
      "recall_number": "Z-0695-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81773",
      "termination_date": "20200429",
      "more_code_info": "",
      "recall_initiation_date": "20181207",
      "postal_code": "45242-2803",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}