FDA Expands Class I Recall of BMC Luna G3 APAP Devices Over Firmware Defects
The FDA has expanded its most serious recall category for BMC Medical's Luna G3 APAP devices, affecting 20,160 units in the U.S.
4 reports on this incident · first at Sep 9, 2026, 1:15 p.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
We last searched for new coverage of this at Sep 9, 2026, 1:41 p.m. ET — checked 1h ago.
Earlier reports
Sep 9, 2026, 1:22 p.m. ET
FDA Upgrades Recall of BMC Luna G3 APAP Devices to Class I
The U.S. Food and Drug Administration has upgraded the recall of BMC Medical Co., Ltd.'s Luna G3 APAP devices to Class I, the agency's most serious recall category, according to an FDA enforcement report. Class I is used when there is a reasonable probability that using the product will cause serious harm or death, per the FDA's recall definitions.
The recall, initiated on August 19, 2026, affects 20,160 Luna G3 APAP units distributed in the United States, as reported by Medical Daily. The agency's enforcement report lists the recall number as Z-2979-2026. The reason for the recall is firmware defects that could result in unintended serious adverse health consequences, and the hazard is that the device stops delivering therapy and shuts itself off.
BMC Medical says it has received no complaints or serious adverse reports linked to the firmware failure, according to Medical Daily. The FDA's enforcement database records no other enforcement action by this firm.
Affected devices running the old version should be discontinued immediately until a replacement device is provided, according to the recall notice.
Sep 9, 2026, 1:18 p.m. ET
FDA Reports Injuries Linked to Recalled BMC Luna G3 APAP Devices
The U.S. Food and Drug Administration (FDA) has received reports of injuries linked to the recalled BMC Luna G3 APAP devices, according to a report from Medical Daily. The agency's enforcement report, dated September 8, 2026, lists the recall as Class I, the FDA's most serious category, used where there is a reasonable probability that using the product will cause serious harm or death.
The recall, initiated August 19, 2026, covers 20,160 Luna G3 APAP units distributed in the United States. The FDA states that firmware defects could result in unintended serious adverse health consequences, and that the device stops delivering therapy and shuts itself off. BMC Medical Co., Ltd. says it has received no complaints or serious adverse reports linked to the firmware failure, according to Medical Daily.
The FDA advises that affected devices running the old version should be discontinued immediately until a replacement device is provided. The recall number is Z-2979-2026. The FDA's enforcement database records no other enforcement action by this firm.
Sep 9, 2026, 1:15 p.m. ETFirst report
FDA Class I Recall Issued for BMC Luna G3 APAP Devices Due to Firmware Defects
The U.S. Food and Drug Administration (FDA) has classified a recall of BMC Medical Co., Ltd.'s Luna G3 APAP devices as Class I, the agency's most serious category, used where there is a reasonable probability that using the product will cause serious harm or death, according to the FDA's recall definitions. The recall, initiated on August 19, 2026, and reported on September 8, 2026, affects 20,160 units distributed in the United States, as reported by Medical Daily.
The recall was issued because firmware defects could result in unintended serious adverse health consequences, specifically the device stopping therapy and shutting itself off. BMC Medical Co., Ltd. says it has received no complaints or serious adverse reports linked to the firmware failure, according to Medical Daily.
The FDA enforcement report, recall number Z-2979-2026, instructs that affected devices running the old version should be discontinued immediately until a replacement device is provided. The FDA's enforcement database records no other enforcement action by this firm, though this history says nothing about the cause of this recall.
The cause of the firmware defect has not been determined.
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- Version 19 Sept 2026, 17:55current
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- Version 19 Sept 2026, 17:15current
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- Version 19 Sept 2026, 17:18current
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- Version 19 Sept 2026, 17:22current
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