FDA Classified BMC Medical APAP Device Recall
The FDA issued a Class I recall for 20,160 Luna G3 APAP units due to a critical firmware defect causing potential shutdowns.
Updated on Oct. 2, 2026 in Asthma
Live Poll
Do you trust that manufacturers sufficiently notify patients when medical devices have significant safety defects?
BMC Medical Co., Ltd. initiated a recall of 20,160 Luna G3 APAP devices after discovering a firmware debug code that could trigger unexpected shutdowns. The FDA classified this action as a Class I recall on August 19, 2026, the most serious type of recall.
Why it matters
The defect poses significant health risks because the device may fail during operation if it encounters extreme pressure and flow conditions, potentially disrupting critical respiratory therapy. While no adverse reports were received, the potential for an unplanned shutdown necessitates urgent intervention for affected users.
The recall involves 20,160 Luna G3 APAP (Model LG3600) devices, with 196 units currently lacking confirmation of the required firmware update. The affected devices were distributed across the United States between October 29, 2024, and July 6, 2026.
The players
BMC Medical Co., Ltd.
This Beijing-based manufacturer produces various respiratory medical devices including CPAP and APAP machines.
FDA
The Food and Drug Administration is the federal agency responsible for regulating medical devices and ensuring public safety.
React Health
React Health acts as the U.S. importer for the devices and manages inquiries related to the current recall status.
The details
The flaw stems from a debug code in firmware version G3-2.00.76 that triggers an error message when the device operates under high pressure, high respiratory rates, and high peak flow simultaneously. BMC Medical has since introduced a firmware update, version G3-2.00.77, to correct the issue, which was applied to many units at the U.S. importer warehouse.
Timeline
Affected units were manufactured from September 11, 2024, to October 18, 2024.
The firmware was upgraded at the importer warehouse between October 2024 and December 2024.
Devices were distributed nationwide from October 29, 2024, to July 6, 2026.
BMC Medical reported the recall to the FDA on July 15, 2026.
The FDA classified the action as a Class I recall on August 19, 2026.
The Big Picture
The recall follows the standard enforcement protocols set by the FDA's Class I recall classification criteria for medical devices that present a reasonable probability of serious adverse health consequences. This reflects the stringent regulatory oversight applied to durable medical equipment that patients rely upon for life-sustaining respiratory assistance.
Users of the Luna G3 APAP should immediately verify their firmware version to determine if their device is part of the affected batch. If a device has not been updated, patients should contact the manufacturer or provider to ensure they have access to a safe, functional unit.
The takeaway
Patients using APAP devices should periodically check manufacturer announcements for firmware updates that are vital for device safety. Prompt action when a recall is announced helps ensure that therapy remains effective and avoids the risk of sudden equipment failure.
Further reading
Learn more about device management and respiratory care in the Asthma section.
More information
Patients can confirm if their unit is affected by utilizing the device recall status check tool.
Source note: This article includes information reported by U.S. Food and Drug Administration.
Live Poll
Do you trust that manufacturers sufficiently notify patients when medical devices have significant safety defects?
