{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Columbia",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73366",
      "recalling_firm": "Ambu Inc.",
      "address_1": "6230 Old Dobbin Ln Ste 250",
      "address_2": "N/A",
      "postal_code": "21045-5955",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Please see attached consignee list",
      "recall_number": "Z-1236-2016",
      "product_description": "Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile   for use as an alternative to a face mask for achieving and maintaining control of the airway during routine  emergency anesthetic procedures.",
      "product_quantity": "Total Numbers of unit distributed: 45990 pes (USA)",
      "reason_for_recall": "Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the  problem  during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product  and,ultimately,patient complications.",
      "recall_initiation_date": "20160210",
      "center_classification_date": "20160324",
      "termination_date": "20160622",
      "report_date": "20160330",
      "code_info": "Catalog Number:408300000    Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239,  1795914      Catalog Number: 408400000  Size #4 All lots from 1632799 through lot number 1790075.      Catalog Number:408500000  Size #5 All lots from 1632802 through lot number 1810863."
    }
  ]
}