Class I Recall Issued for BMC Medical Luna G3 APAP Devices Due to Device Shutdown Risk

The FDA has classified a Class I recall, its most serious type, for BMC Medical Co., Ltd.'s Luna G3 APAP devices (model LG3600) with firmware version G3-2.00.76. The recall, initiated due to a risk of the device shutting down if operating simultaneously under high pressure, high respiratory rate, and high peak flow, affects products distributed nationwide between October 29, 2024, and July 6, 2026.