{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "West Chester",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92899",
      "recalling_firm": "Tytek Medical Inc",
      "address_1": "8904 Beckett Rd",
      "address_2": "",
      "postal_code": "45069-7054",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK",
      "recall_number": "Z-2610-2023",
      "product_description": "TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax  Model Number: TM-303",
      "product_quantity": "439146 units",
      "reason_for_recall": "Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and  (2) improve the artwork showing placement site location",
      "recall_initiation_date": "20201005",
      "center_classification_date": "20230919",
      "termination_date": "20260313",
      "report_date": "20230927",
      "code_info": "UDI: 00855204008006  All lots produced prior to Oct 5, 2020",
      "more_code_info": ""
    }
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}