{
  "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": "Placentia",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85288",
      "recalling_firm": "Bioseal Corporation",
      "address_1": "167 W Orangethorpe Ave",
      "address_2": "N/A",
      "postal_code": "92870-6922",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution including in the state of CA.",
      "recall_number": "Z-2795-2020",
      "product_description": "Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.",
      "product_quantity": "900 units",
      "reason_for_recall": "The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.",
      "recall_initiation_date": "20190815",
      "center_classification_date": "20200813",
      "termination_date": "20210304",
      "report_date": "20200819",
      "code_info": "Bioseal Part # TRAX01/50  Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476"
    }
  ]
}