On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers. On August 19, 2026, the FDA classified this retrospective recall as a Class I recall (FDA Recall Number: Z-2979-2026).

BMC has identified that firmware version, G3-2.00.76 installed on these Luna G3 APAP (Model LG3600) devices contained a firmware defect. BMC conducted a firmware upgrade of these devices to version G3-2.00.77 for 20,160 affected devices at the U.S. importer’s warehouse from October through December 2024. After reporting the retrospective recall, BMC discovered that potentially up to 196 units did not receive the upgrade and identified that these devices may still contain firmware version G3-2.00.76.

If the affected device(s) operates simultaneously under high pressure, high respiratory rate, and high peak flow an “Error” message on the device display is triggered, followed by automatic shutdown resulting in a failure to deliver therapy.

The firmware defects could result in unintended serious adverse health consequences. To date, BMC has received no complaints or serious adverse reports associated with this firmware failure.

Impacted products were manufactured from September 11, 2024, to October 18, 2024, and distributed by BMC to its U.S. importer, React Health (RH), from September 20, 2024, to October 19, 2024. Impacted products were distributed nationwide between October 29, 2024, through July 6, 2026.

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