{
  "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 III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90386",
      "recalling_firm": "Synapse Biomedical Inc",
      "address_1": "300 Artino St",
      "address_2": "N/A",
      "postal_code": "44074-1263",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV.  Foreign distribution pending.",
      "recall_number": "Z-1393-2022",
      "product_description": "NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers:    Part #\t             Part Name  20-0035\t      NeuRx DPS System Kit  20-0036\t      NeuRx Diaphragm Pacing System, Patient Kit, SCI  20-0028\t      NeuRx DPS Surgical Kit, HDE  20-0040\t      NeuRx Diaphragm Pacing System Spare Sterile Components  21-0001-99\tMapping Probe  21-0004-99\tIndifferent Electrode  21-0007-99\tLead Tunneler Set  21-0009-99\tBlue Cable Set  21-0010-99\tTransducer Tubing  21-0017-99\tPermaLoc Electrode  21-0023-99\tGreen Cable  21-0024-99\tOrange Cable  21-0025-99\tYellow Cable  21-0026-99\tWhite Cable  77-0050\t      Surgeon Instruction Manual  20-0045       \tNeuRx DPS System Kit, ALS HDE  20-0046\t      NeuRx Diaphragm Pacing System, Patient Kit, ALS      Marketed under HDE H070003 as well as H100006",
      "product_quantity": "71",
      "reason_for_recall": "Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).",
      "recall_initiation_date": "20220531",
      "center_classification_date": "20220718",
      "termination_date": "20240411",
      "report_date": "20220727",
      "code_info": "UDI-DI: 00852184003007 00852184003045 00852184003038 00852184003267 00852184003090 00852184003106 00852184003113 00852184003120 00852184003137 00852184003144 00852184003151 00852184003168 00852184003175 00852184003182 00852184003281 00852184003052  Lots/Serial Numbers:  20-0035-113021-3-3 20-0035-120221-2-1 20-0035-121621-5-2 20-0035-121621-5-3 20-0035-010722-5-4 20-0035-010722-5-5 20-0035-030722-2-2 20-0035-031122-5-1 20-0035-031122-5-2 20-0035-031122-5-5 20-0035-033122-5-1 20-0035-033122-5-2 20-0035-033122-5-3 20-0035-040622-4-1 20-0035-040622-4-2 20-0035-040622-4-3 20-0035-040622-4-2 20-0035-042122-1-1  20-0028-060221-5 20-0028-062421-5 20-0028-062521-5 20-0028-072821-5 20-0028-031022-5  20-0040-012221-10 20-0040-012221-10 20-0040-021921-9 20-0040-012221-10 20-0040-012221-10 20-0040-021921-9 20-0040-021921-9 20-0040-021921-9 20-0040-021921-9 20-0040-012621-10 20-0040-012621-10 20-0040-012621-10 20-0040-012621-10 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-071321-6 20-0040-071321-6 20-0040-092021-10 20-0040-092021-10 20-0040-071521-2 20-0040-092021-10 20-0040-092021-10 20-0040-092021-10 20-0040-100721-10 20-0040-100721-10 20-0040-100721-10 20-0040-100721-10 20-040-100721-10 20-0040-100721-10 20-0040-100721-10 20-0040-122121-10 20-0040-122121-10 20-0040-122121-10 20-0040-122121-10 20-0040-010622-10 20-0040-121621-1 20-0040-020822-10 20-0040-010622-10 20-0040-040122-2"
    }
  ]
}