{
  "leg": "device",
  "source": "openFDA (FDA)",
  "source_url": "https://open.fda.gov",
  "query": "bipap",
  "total": 19,
  "open_count": 13,
  "class_i_count": 13,
  "records": [
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "DreamStation Auto BiPAP. Non-Continuous Ventilator.",
      "reason": "Devices may possess a programming error resulting in an incorrect device configuration.",
      "date": "2025-08-20",
      "recall_number": "Z-2228-2025",
      "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-2228-2025"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.   BiPAP A40 Pro - sold OUS",
      "reason": "This device does not indicate for use in patients with respiratory failure.",
      "date": "2025-07-09",
      "recall_number": "Z-2037-2025",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2037-2025"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.",
      "reason": "This device does not indicate for use in patients with respiratory failure.",
      "date": "2025-07-09",
      "recall_number": "Z-2035-2025",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2035-2025"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg.   BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.",
      "reason": "This device does not indicate for use in patients with respiratory failure.",
      "date": "2025-07-09",
      "recall_number": "Z-2036-2025",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2036-2025"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP V30 Auto Ventilator, Part Number 1111178",
      "reason": "Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.",
      "date": "2024-05-29",
      "recall_number": "Z-1812-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1812-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A40 Ventilators:    BiPAP A40, Part Numbers 1111169 (US and OUS)  and   (OUS ONLY)1111170  1111171  1111173  1111174  1111175  1111177  1116156  1111170S  BR1111169  CN1111169  IT1111169  R1111169  R1111177  R1116156  ;    BiPAP A40 Pro, Part Numbers (OUS Only):  ARX3100S19  AUX3100S19  BLX3100S19  BRX3100S18  CAX3100S12  CAX3100T12  DEX3100S13  EEX3100S19  ESX3100S19  FRX3100S14  GBX3100H19  GBX3100S19  IAX3100S19  INX3100H19  INX3100S19  ITX3100S21  SPX3100S19  ;  BiPAP A40 EFL, Part Numbers (OUS Only):  AUX3000S19  DEX2900S13  DEX3000S13  EEX3000S19  ESX3000S19  FRX3000S14  GBX3000S19  INX3000H19  ITX3000S21",
      "reason": "Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.",
      "date": "2024-05-29",
      "recall_number": "Z-1813-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1813-2024"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A30 Ventilator, Part Number 1111143 (US and OUS)  OUS Only:  Part Numbers   1111144  1111145  1111147  1111148  1111149  1111150  1111154  1111181  1116155  1111144L  1111144M  1111144V  BR1111143  CN1111143  R1111143  R1111150  R1111181",
      "reason": "Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.",
      "date": "2024-05-29",
      "recall_number": "Z-1814-2024",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1814-2024"
    },
    {
      "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": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "Philips BiPAP A30, Rx Only.  To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.",
      "reason": "Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.",
      "date": "2022-09-14",
      "recall_number": "Z-1654-2022",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY.  Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1654-2022"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "Philips BiPAP V30 Auto, Rx Only.  To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.",
      "reason": "Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.",
      "date": "2022-09-14",
      "recall_number": "Z-1656-2022",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY.  Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1656-2022"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "Philips BiPAP A40, Rx Only.  To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.",
      "reason": "Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.",
      "date": "2022-09-14",
      "recall_number": "Z-1655-2022",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY.  Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1655-2022"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting",
      "reason": "The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.",
      "date": "2021-07-21",
      "recall_number": "Z-1958-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1958-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use",
      "reason": "The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.",
      "date": "2021-07-21",
      "recall_number": "Z-1957-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1957-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting.  Material Number: R1111177",
      "reason": "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.",
      "date": "2021-06-02",
      "recall_number": "Z-1627-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1627-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A30, Brazil: Continuous ventilator, non-life-supporting.  Material Number: BR1111143",
      "reason": "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.",
      "date": "2021-06-02",
      "recall_number": "Z-1629-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1629-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting.  Material Number: 1111177",
      "reason": "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.",
      "date": "2021-06-02",
      "recall_number": "Z-1628-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1628-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A40, Brazil: Continuous ventilator, non-life-supporting.  Material Number: BR1111169",
      "reason": "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.",
      "date": "2021-06-02",
      "recall_number": "Z-1630-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1630-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP A40, China:  Continuous ventilator, non-life-supporting. Material Number - CN1111169",
      "reason": "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.",
      "date": "2021-06-02",
      "recall_number": "Z-1626-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1626-2021"
    },
    {
      "kind": "enforcement",
      "classification": "Class II",
      "status": "Terminated",
      "firm": "Philips Respironics, Inc.",
      "product": "BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178",
      "reason": "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.",
      "date": "2021-06-02",
      "recall_number": "Z-1625-2021",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1625-2021"
    }
  ],
  "api_urls": [
    "https://api.fda.gov/device/enforcement.json?search=product_description:%22bipap%22&sort=report_date:desc&limit=30",
    "https://api.fda.gov/device/recall.json?search=product_res_name:%22bipap%22&sort=event_date_initiated:desc&limit=30"
  ],
  "contradiction": {
    "sellerClaim": "“Works great, never had any issues, definitely not recalled.”",
    "officialRecord": "FDA records show 19 recall/enforcement records matching this model — including 13 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."
}