{
  "leg": "device",
  "source": "openFDA (FDA)",
  "source_url": "https://open.fda.gov",
  "query": "cpap",
  "total": 13,
  "open_count": 7,
  "class_i_count": 9,
  "records": [
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "DreamStation Auto CPAP. Non-Continuous Ventilator.",
      "reason": "Devices may possess a programming error resulting in an incorrect device configuration.",
      "date": "2025-08-20",
      "recall_number": "Z-2227-2025",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2227-2025"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Smiths Medical Asd Inc.",
      "product": "paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N",
      "reason": "Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.",
      "date": "2024-10-02",
      "recall_number": "Z-3090-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-3090-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Smiths Medical Asd Inc.",
      "product": "paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N",
      "reason": "Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.",
      "date": "2024-10-02",
      "recall_number": "Z-3091-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-3091-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Smiths Medical Asd Inc.",
      "product": "Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX",
      "reason": "There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.",
      "date": "2024-09-18",
      "recall_number": "Z-2974-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2974-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Smiths Medical Asd Inc.",
      "product": "smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS",
      "reason": "When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath.  This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.",
      "date": "2024-03-27",
      "recall_number": "Z-1274-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Singapore, Slovakia, Slovenia, Saudi Arabia, South Africa, Spain, Sweden, Tawain, Province of China, Thailand, Trinidad and Tobago, Turkey, United Kingdom and Viet Nam.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1274-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Smiths Medical Asd Inc.",
      "product": "smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS",
      "reason": "When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath.  This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.",
      "date": "2024-03-27",
      "recall_number": "Z-1275-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Singapore, Slovakia, Slovenia, Saudi Arabia, South Africa, Spain, Sweden, Tawain, Province of China, Thailand, Trinidad and Tobago, Turkey, United Kingdom and Viet Nam.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1275-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.  Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.",
      "reason": "A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.",
      "date": "2023-04-12",
      "recall_number": "Z-1322-2023",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "US Nationwide. France, Reunion.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1322-2023"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Terminated",
      "firm": "Compass Health Brands (Corporate Office)",
      "product": "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.",
      "reason": "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.",
      "date": "2018-08-29",
      "recall_number": "Z-2741-2018",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2741-2018"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Zoll Medical Corporation",
      "product": "731 Series Ventilators running software version 05.20.00     The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an  MRI conditional  label, they are suitable for use in an MRI environment with appropriate precautions. The ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The EMV+¿ and Eagle II  (with and without MRI label) have a full range of ventilation modes (AC, SIMV with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV¿ provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy¿ to-use, durable,",
      "reason": "A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.",
      "date": "2018-03-07",
      "recall_number": "Z-0812-2018",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Outside US",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-0812-2018"
    },
    {
      "kind": "enforcement",
      "classification": "Class III",
      "status": "Terminated",
      "firm": "Devilbiss Healthcare Llc",
      "product": "DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure.  Used in home and clinical environments.",
      "reason": "A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as \"RUN-TEST\".",
      "date": "2014-07-09",
      "recall_number": "Z-1949-2014",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1949-2014"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Terminated",
      "firm": "Fisher & Paykel Healthcare, Ltd.",
      "product": "Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal.    CPAP Prongs (10 pack):  Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10.    Bubble CPAP Starter Kits:  Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK.    The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.",
      "reason": "The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.",
      "date": "2014-05-28",
      "recall_number": "Z-1539-2014",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide Distribution - USA (nationwide) and Internationally to:  ARGENTINA  AUSTRALIA  BANGLADESH  BELGIUM  CANADA  CHILE  CHINA  FRANCE  GERMANY  GREAT BRITAIN  GREECE  HUNGARY  INDIA  INDONESIA  IRAQ  ISRAEL  ITALY  JAPAN  LIBYA  MALAYSIA  NEPAL  NETHERLANDS  NEW ZEALAND  PERU  POLAND  PORTUGAL  QATAR  ROMANIA  RUSSIA  RWANDA  SAUDI ARABIA  SOUTH AFRICA  SPAIN  SRI LANKA  SWITZERLAND  TAIWAN  THAILAND  TRINIDAD & TOBAGO  TURKEY  UNITED ARAB EMIRATES",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1539-2014"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Vital Signs Colorado Inc.",
      "product": "Vital Signs Anesthesia Circuits    The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.",
      "reason": "A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.",
      "date": "2014-01-29",
      "recall_number": "Z-0812-2014",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Lebanon, South Korea, Finland, United Arab Emirates, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-0812-2014"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Fisher & Paykel Healthcare, Ltd.",
      "product": "Fisher & Paykel  Healthcare ICON CPAP (continuous positive airway pressure).    Models:    ICON Auto:  ICONAAN, ICONAAN-HT, ICONAAJ.  ICON Novo:  ICONNAN, ICONNAN-HT, ICONNAJ.  ICON Premo:  ICONPBN, ICONPBN-HT, ICONPBN-HTC.    The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.",
      "reason": "Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP.  These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.",
      "date": "2013-06-05",
      "recall_number": "Z-1437-2013",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1437-2013"
    }
  ],
  "api_urls": [
    "https://api.fda.gov/device/enforcement.json?search=product_description:%22cpap%22&sort=report_date:desc&limit=30",
    "https://api.fda.gov/device/recall.json?search=product_res_name:%22cpap%22&sort=event_date_initiated:desc&limit=30"
  ],
  "contradiction": {
    "sellerClaim": "“Works great, never had any issues, definitely not recalled.”",
    "officialRecord": "FDA records show 13 recall/enforcement records matching this model — including 9 Class I (most serious). Most recent: Class I — Devices may possess a programming error resulting in an incorrect device configuration. (2025-08-20, Philips Respironics, Inc.).",
    "verdict": "conflict"
  },
  "disclaimer": "Informational only — not medical advice and not a safety determination. This reports recall/enforcement records in the openFDA database matching the model name you entered. It does not confirm that a specific used unit is or is not affected — recalls apply to specific model numbers, lots, and serial/date ranges. Always verify your exact model and serial number against the official FDA notice linked here and the manufacturer before using or buying a used medical device."
}