FDA Recalled Luna G3 APAP Devices Over Firmware Defect
Owners of certain sleep apnea devices should verify if their unit received a critical firmware safety update.
Updated on Oct. 2, 2026 in Asthma
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The FDA issued a Class I recall for 20,160 Luna G3 APAP devices after a firmware defect was found to trigger unexpected shutdowns. The recall, reported on July 15, 2026, impacts units distributed across the United States between October 2024 and July 2026.
Why it matters
This recall addresses a software error that could cause respiratory therapy equipment to stop functioning during use. Because this is a Class I recall, it represents the most serious type, where use of the product may cause serious injury or death.
A manufacturer recall filing identified a firmware defect in 20,160 Luna G3 APAP units. While 196 units remain unconfirmed for an upgrade, no adverse reports or complaints were linked to the defect.
The players
BMC Medical
A Beijing-based medical device manufacturer specializing in respiratory and sleep therapy equipment.
FDA
The federal agency responsible for overseeing the safety and efficacy of medical devices in the United States.
React Health
The distributor handling consumer inquiries regarding the recall status of these devices.
The details
The defect stems from a debug code embedded in firmware version G3-2.00.76. This code causes the device to error out and shut down when it operates under a combination of high pressure, high respiratory rate, and high peak flow. BMC Medical has released a firmware patch, version G3-2.00.77, to resolve the issue.
Timeline
September 11, 2024 – October 18, 2024: Manufacturing period for the affected Luna G3 APAP devices.
October 29, 2024 – July 6, 2026: Nationwide distribution period for the impacted devices.
July 15, 2026: BMC Medical officially reported the recall to the FDA.
August 19, 2026: The FDA officially classified the action as a Class I recall.
Health Landscape
This action follows the standard FDA Class I recall protocol, which is reserved for devices where there is a reasonable probability that use will cause serious adverse health consequences. It highlights the reliance of modern respiratory care on stable software architecture to ensure patient safety.
If you use a Luna G3 APAP device, contact your equipment provider or visit the manufacturer's website to confirm your firmware version. It is essential to discuss any recurring error messages or unexpected power-offs with your physician immediately.
The takeaway
Class I recalls are serious alerts meant to prevent device failure during critical medical use. Always verify your device's serial number against official manufacturer recall lists if you receive notification of a potential defect.
Further reading
Learn more about the latest updates in respiratory care by visiting Asthma.
More information
Check your unit’s safety status using the device recall status check tool or contact React Health at 863-226-6285.
Source note: This article includes information reported by U.S. Food and Drug Administration.
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