Is it safe to buy a used cpap? — 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 13 FDA recall record(s) · 9 Class I
openFDA device recall/enforcement records matching cpap right now. Open/ongoing: 7.
Seller says: “Works great, never had any issues, definitely not recalled.”
The record says: 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.).
DreamStation Auto CPAP. Non-Continuous Ventilator. Class I
Philips Respironics, Inc. · Ongoing · 2025-08-20 · Z-2227-2025
Devices may possess a programming error resulting in an incorrect device configuration.
View official FDA notice →
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Class I
Smiths Medical Asd Inc. · Ongoing · 2024-10-02 · Z-3090-2024
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.
View official FDA notice →
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N Class I
Smiths Medical Asd Inc. · Ongoing · 2024-10-02 · Z-3091-2024
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.
View official FDA notice →
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX Class I
Smiths Medical Asd Inc. · Ongoing · 2024-09-18 · Z-2974-2024
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.
View official FDA notice →
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS Class I
Smiths Medical Asd Inc. · Ongoing · 2024-03-27 · Z-1274-2024
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 posi
View official FDA notice →
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS Class I
Smiths Medical Asd Inc. · Ongoing · 2024-03-27 · Z-1275-2024
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 posi
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 →
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 a Class I
Compass Health Brands (Corporate Office) · Terminated · 2018-08-29 · Z-2741-2018
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 d
View official FDA notice →
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of i Class II
Zoll Medical Corporation · Terminated · 2018-03-07 · Z-0812-2018
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
View official FDA notice →
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Class III
Devilbiss Healthcare Llc · Terminated · 2014-07-09 · Z-1949-2014
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".
View official FDA notice →
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, Class I
Fisher & Paykel Healthcare, Ltd. · Terminated · 2014-05-28 · Z-1539-2014
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
View official FDA notice →
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a v Class II
Vital Signs Colorado Inc. · Terminated · 2014-01-29 · Z-0812-2014
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.
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.