FDA recall, , High risk
BMC Luna G3 APAP Machines
The firmware defects could result in unintended serious adverse health consequences.
BMC Medical lists the affected products
Summary by Recall Canary from the FDA notice
What happened
BMC Medical Co., Ltd., of Beijing, China, recalled 20,160 BMC/Reacthealth Luna G3 Apap REF LG 3600 devices because the firmware version G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect. The recall was retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse. The company began the recall on July 15, 2026, and the FDA added it to the Enforcement Report on August 19, 2026.
The devices were distributed in the US to Florida; no other states were listed. The company announced the recall on September 7, 2026.
What to do
If a code on your device is listed below:
- Alternately, customer should contact React Health (RH), the U.S. Importer for BMC, via email at: 3B-Recall@
reacthealth.com for replacement of the uncorrected Luna G3 APAP (LG3600) device, firmware version: G3-2.00.76 with a new device for the prescribed therapy. - Users of the Luna G3 APAP (Model LG3600) who have the device can check their firmware version by.
- Obtain the device SN (please locate the SN from the label on the rear of the device as shown in the figure below) → Access the inquiry webpage (https://en.bmc-medical.com/rc-adh.html) → Enter the SN (input the obtained SN in the “Serial Number(SN)” box at the top of the webpage) → Click “Check My Device” to perform the query → Obtain the firmware version of the device.
- Affected devices operating with version G3-2.00-76 should be discontinued immediately until a replacement device is provided.
Is yours affected?
BMC Medical lists the affected products on its website. A product missing from this page may still be recalled.
Look up your product on en.bmc-medical.com/rc-adh.html (opens in a new tab)
A UDI-DI is the device identifier printed with the barcode on the device label.
Luna G3 Apap
- Model number
- LG3600
- UDI-DI
- 06948538363331
- 06948538365892
- 124937331
Recall details
- Company began the recall
- Sold in
US distribution to: Florida OUS: None
- Company
- BMC Medical Co., Ltd.Beijing, China
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99445
- Recall number
- Z-2979-2026
- Quantity recalled
- 20,160 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Announced by the company
Summary updated
