{
  "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": [
    {
      "country": "United States",
      "city": "Middleburg Heights",
      "address_1": "6753 Engle Rd",
      "reason_for_recall": "A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility.",
      "address_2": "",
      "product_quantity": "742",
      "code_info": "All units manufactured after May 1, 2015",
      "center_classification_date": "20180820",
      "distribution_pattern": "US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.",
      "state": "OH",
      "product_description": "CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L    Product Usage:  A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.",
      "report_date": "20180829",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Compass Health Brands (Corporate Office)",
      "recall_number": "Z-2741-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80545",
      "termination_date": "20200505",
      "more_code_info": "",
      "recall_initiation_date": "20180618",
      "postal_code": "44130-7934",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}