Is it safe to buy a used bipap? — check the FDA recall record
We can't tell you if it's "safe" — but we can show you the FDA recall/enforcement record and the seller-claim-vs-record contradiction.
Result 19 FDA recall record(s) · 13 Class I
openFDA device recall/enforcement records matching bipap right now. Open/ongoing: 13.
Seller says: “Works great, never had any issues, definitely not recalled.”
The record says: 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.).
DreamStation Auto BiPAP. Non-Continuous Ventilator. Class I
Philips Respironics, Inc. · Ongoing · 2025-08-20 · Z-2228-2025
Devices may possess a programming error resulting in an incorrect device configuration.
View official FDA notice →
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Class I
Philips Respironics, Inc. · Ongoing · 2025-07-09 · Z-2037-2025
This device does not indicate for use in patients with respiratory failure.
View official FDA notice →
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg. Class I
Philips Respironics, Inc. · Ongoing · 2025-07-09 · Z-2035-2025
This device does not indicate for use in patients with respiratory failure.
View official FDA notice →
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Class I
Philips Respironics, Inc. · Ongoing · 2025-07-09 · Z-2036-2025
This device does not indicate for use in patients with respiratory failure.
View official FDA notice →
BiPAP V30 Auto Ventilator, Part Number 1111178 Class I
Philips Respironics, Inc. · Ongoing · 2024-05-29 · Z-1812-2024
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
View official FDA notice →
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 Class I
Philips Respironics, Inc. · Ongoing · 2024-05-29 · Z-1813-2024
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
View official FDA notice →
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111 Class I
Philips Respironics, Inc. · Ongoing · 2024-05-29 · Z-1814-2024
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
View official FDA notice →
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to Class I
Philips Respironics, Inc. · Ongoing · 2023-04-12 · Z-1322-2023
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 sett
View official FDA notice →
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respira Class I
Philips Respironics, Inc. · Ongoing · 2022-09-14 · Z-1654-2022
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
View official FDA notice →
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and re Class I
Philips Respironics, Inc. · Ongoing · 2022-09-14 · Z-1656-2022
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
View official FDA notice →
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respira Class I
Philips Respironics, Inc. · Ongoing · 2022-09-14 · Z-1655-2022
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
View official FDA notice →
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting Class I
Philips Respironics, Inc. · Ongoing · 2021-07-21 · Z-1958-2021
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.
View official FDA notice →
Source: openFDA (U.S. FDA) · JSON
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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.