FDA Posts BMC Medical's Class I Recall Announcement for Luna G3 APAP Devices

The Food and Drug Administration on September 8 published a recall announcement from BMC Medical Co., Ltd. covering Luna G3 APAP sleep apnea devices that ran a firmware version the company said contained a defect. The agency has classified the recall as Class I.

According to the company announcement posted by the FDA, BMC, based in Beijing, retrospectively reported to the agency on July 15, 2026 a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States. The announcement states that the corrective action was not reported to customers. The FDA classified the recall as Class I on August 19 under recall number Z-2979-2026.

What the company reported

BMC said firmware version G3-2.00.76 on the devices contained the defect, and that it upgraded 20,160 affected devices to version G3-2.00.77 at the U.S. importer's warehouse between October and December 2024. After reporting the recall, BMC found that up to 196 units cannot be confirmed to have received the upgrade.

As summarized by Respiratory Therapy on September 8, the alert said that if an affected device operates simultaneously under high pressure, high respiratory rate and high peak flow, an error message is triggered, followed by automatic shutdown and a failure to deliver therapy. BMC said it has received no complaints or serious adverse reports associated with the failure.

The affected devices were manufactured between September 11 and October 18, 2024, and distributed by BMC to its U.S. importer, React Health, which shipped them nationwide between October 29, 2024 and July 6, 2026, according to the announcement. The notice lists two device identifiers and points users to a BMC web page where a serial number can be checked. It directs inquiries and replacement requests to React Health. At publication, the notice stated that affected devices running the older firmware "should be discontinued immediately until a replacement device is provided," according to Respiratory Therapy's account.

Earlier warning letter

The recall follows a warning letter the FDA sent BMC on May 20, 2026, after a December 2025 inspection of 3B Medical, Inc., which does business as React Health, in Dublin, Ohio. The letter said the Luna G3 APAP devices were misbranded because BMC failed to submit a report of correction or removal within 10 working days of initiating the firmware update.

In the letter, the FDA wrote that firmware G3-2.00.76 "could cause the Luna G3 APAP device to unexpectedly shut down during use, which causes loss of therapy for patients with obstructive sleep apnea." The agency said BMC had not submitted that report as of May 19, 2026.

The same letter said BMC's G3X APAP devices were adulterated and misbranded because the company made significant design changes to its cleared Luna CPAP and Auto CPAP system, including new event-detection firmware, without submitting a new 510(k) premarket notification. The FDA asked BMC to respond within 15 business days with the steps it has taken to address the violations.