{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Oberlin",
      "state": "OH",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90626",
      "recalling_firm": "Synapse Biomedical Inc",
      "address_1": "300 Artino St",
      "address_2": "",
      "postal_code": "44074-1263",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "distribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and SC; Germany and Kuwait.  ***Updated 3/28/23 - Product was not distributed to United Arab Emirates. Product was distributed to Kuwait.***  Updated 9.14.23 - 1 patient in Germany, 1 patient in the Czech Republic, 1 distributor in Kuwait",
      "recall_number": "Z-1561-2022",
      "product_description": "NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.",
      "product_quantity": "118 (112 US, 6 OUS)",
      "reason_for_recall": "Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly.",
      "recall_initiation_date": "20220711",
      "center_classification_date": "20220822",
      "termination_date": "20231024",
      "report_date": "20220831",
      "code_info": "UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017",
      "more_code_info": ""
    }
  ]
}