{
  "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": "Ongoing",
      "city": "Murrysville",
      "state": "PA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89276",
      "recalling_firm": "Philips Respironics, Inc.",
      "address_1": "1001 Murry Ridge Ln",
      "address_2": "",
      "postal_code": "15668-8517",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: Distributed to the following US states:  AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.",
      "recall_number": "Z-0494-2022",
      "product_description": "Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257    The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.",
      "product_quantity": "205 kits",
      "reason_for_recall": "Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers.  A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.",
      "recall_initiation_date": "20211222",
      "center_classification_date": "20220121",
      "report_date": "20220202",
      "code_info": "Lot Numbers 210414 - 210524",
      "more_code_info": ""
    }
  ]
}