{
  "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": "2026-09-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rastatt",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99668",
      "recalling_firm": "Maquet Cardiopulmonary Gmbh",
      "address_1": "Kehler Str. 31",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;",
      "recall_number": "Z-3146-2026",
      "product_description": "Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);",
      "product_quantity": "16697 units (492 USA, 16205 OUS)",
      "reason_for_recall": "The packaging may not consistently maintain sterile barrier integrity.",
      "recall_initiation_date": "20260731",
      "center_classification_date": "20260911",
      "report_date": "20260923",
      "code_info": "Model Number (USA): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333822, 3000353373, 3000359477, 3000364060, 3000373784, 3000379853, 3000393466, 3000403658, 3000413596, 3000434593, 3000444270, 3000449725, 3000453328, 3000478750, 3000524542;   Model Number (OUS): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333821, 3000333822, 3000341452, 3000349478, 3000353373, 3000356330, 3000359477, 3000364060, 3000370472, 3000373784, 3000379853, 3000387894, 3000389007, 3000393466, 3000395576, 3000403658, 3000411197, 3000413596, 3000418475, 3000434593, 3000438011, 3000441822, 3000444270, 3000449725, 3000453328, 3000461221, 3000466027, 3000468435, 3000471532, 3000478750, 3000485149, 3000489899, 3000501535, 3000508513, 3000518008, 3000524542, 3000525465, 3000526923, 3000534009, 3000539532, 3000541224;",
      "more_code_info": ""
    }
  ]
}