{
  "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": [
    {
      "status": "Terminated",
      "city": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85197",
      "recalling_firm": "Acutus Medical Inc",
      "address_1": "2210 Faraday Ave Ste 100",
      "address_2": "N/A",
      "postal_code": "92008-7225",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: CA,SC, AZ  OUS: None",
      "recall_number": "Z-1768-2020",
      "product_description": "Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly",
      "product_quantity": "108 units",
      "reason_for_recall": "It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.",
      "recall_initiation_date": "20200225",
      "center_classification_date": "20200423",
      "termination_date": "20210427",
      "report_date": "20200429",
      "code_info": "Affected Lot Numbers/Expiration Date:  19040503 /April 2020  19052007 /May 2020  19061317 /June 2020"
    }
  ]
}