{
  "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": [
    {
      "country": "United States",
      "city": "Portage",
      "address_1": "4100 E Milham Ave",
      "reason_for_recall": "Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality.  The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning.  Warning Labels, which are pending distribution, are required on all Neptune devices.   Further investigation found the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. FDA advises Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) not be used.  However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.",
      "address_2": "",
      "product_quantity": "10,394 domestic, 276 international",
      "code_info": "Neptune 2 Rover Ultra (120 V) 0702-001-000  Neptune 2 Rover Ultra (230 V) 0702-002-000  associated IFU 0702-002-700",
      "center_classification_date": "20120814",
      "distribution_pattern": "Worldwide Distribution -- USA (nationwide) and country of: Canada.  .",
      "state": "MI",
      "product_description": "Neptune Rover Waste Management System, Neptune 2 Ultra  Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.",
      "report_date": "20120822",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "recall_number": "Z-2064-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61747",
      "termination_date": "20160823",
      "more_code_info": "",
      "recall_initiation_date": "20120608",
      "postal_code": "49002-9704",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}