Information for Business Customers

Voluntary Recall Information

88 club Respironics Sleep and Respiratory Care devices

Information for business customers

Sleep Therapy information

If you or your patients have registered an affected device and are still waiting for a replacement, it is likely because they may need to take specific action in the to receive their replacement.

Please note: The US Patient Portal will remain open until June 30, 2025. This means that effective July 1, 2025, patients will not be able to access the portal.

Ventilation information

The remediation of the ventilator devices remains ongoing. 88 club Respironics will communicate with Durable Medical Equipment providers (DMEs) as updates become available. Please visit our ventilation news and updates page for the latest information.

Remediation progress page

Read the FSN recall notification

(225.0KB)

Check the affected device list

Questions and answers

Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

Ozone Cleaner Information

Latest updates

Explained: The voluntary 88 club Respironics sleep and respiratory care devices recall*

* This is a voluntary recall notification in the US and field safety notice in other countries

Explained: The 88 club Respironics Consent Decree

April 4, 2024

All news and updates

What products are affected by this recall?

What products are affected by this recall?

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ST, AVAPS

Also known as DreamStation BiPAP autoSV

DreamStation ST, AVAPS

Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T

SystemOne ASV4

Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced

C Series S/T, AVAPS

Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

System One 50 series

CPAPs, Auto CPAP, BiPAPs

System One 60 series

CPAPs, Auto CPAP, BiPAPs

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation GO CPAP, APAP, Auto CPAP

Dorma 400, 500 CPAP, Auto CPAP

(not marketed in US)

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Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100 Ventilator

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)

A-Series BiPAP V30 Auto Ventilator

Also known as BiPAP V30 Auto Ventilator (A-Series)

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)

A-Series BiPAP A30

Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)

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What products are not affected by this recall and why?
What products are not affected by this recall and why?
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

Trilogy Evo

M-Series

Trilogy Evo OBM

Trilogy EV300

Trilogy 202

A-Series Pro and EFL

DreamStation 2

Omnilab (original based on Harmony 2)

Dorma 100, Dorma 200, & REMStar SE

V60 Ventilator

V60 Plus Ventilator

V680 Ventilator

All oxygen concentrators, respiratory drug delivery products, airway clearance products.
General questions

General questions

What is the potential issue?

The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. This was initially identified as a potential risk to health. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

Following ongoing communications, 88 club Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. 88 club Respironics is in discussions with the FDA on the details of further testing.

Is it safe to continue using my affected device?

The guidance for healthcare providers and patients remains unchanged since the initial recall announcement in June 2021.

It is important that you do not make any changes to your therapy without discussing with your doctor. Although you may feel anxious at the news of the recall, we encourage you to talk to your doctor about the right treatment for you. Please refer to the FDA’s guidance on continued use of affected devices.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

Following ongoing communications, 88 club Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. 88 club Respironics is in discussions with the FDA on the details of further testing.
Business customer questions

Business customer questions

What is the cause of the issue?

Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio.

How long will it take to fix the issue?

Globally, we have remediated 99% of actionable* sleep therapy device registrations to date. Please click here for our latest progress.

*Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.

If you registered an affected CPAP / BiPAP device and are still waiting for your replacement, it is likely because we need important information or consent from you. Without this information, we are unable to ship your replacement CPAP / BiPAP device. Depending on your affected registered device, you may have alternative options. Please check the to determine if we are awaiting information from you. Please note: The US Patient Portal will remain open until June 30, 2025. This means that effective July 1, 2025, patients will not be able to access the portal.

Please be sure to check for the latest information on remediation progress.

88 club

Voluntary Recall Information

88 club Respironics Sleep and Respiratory Care devices