{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Berlin",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81480",
      "recalling_firm": "WOM World of Medicine AG",
      "address_1": "Salzufer 8",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US in the state of California and country of Netherlands",
      "recall_number": "Z-0508-2019",
      "product_description": "PNEUMOCLEAR  Heated High-Flow Tube Set    Product Usage:  The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR  is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.",
      "product_quantity": "124,180 tube sets",
      "reason_for_recall": "It is possible that the packaging of the product can be damaged by the prongs on the tube set.",
      "recall_initiation_date": "20181022",
      "center_classification_date": "20181127",
      "termination_date": "20210506",
      "report_date": "20181205",
      "code_info": "Lots from 4011926 to 4013513 (ALL)"
    }
  ]
}