Luna G3 APAP Recall: How to Check the Firmware Defect and What Owners Should Do

• The FDA published a September 8, 2026 recall for certain BMC Luna G3 APAP Model LG3600 devices with firmware version G3-2.00.76.
• The affected firmware may cause an Error message and automatic shutdown during high-pressure, high-respiratory-rate, and high-peak-flow conditions.
• Owners should check the device serial number through BMC’s official recall tool and stop using a device confirmed to have G3-2.00.76 until React Health provides a replacement.

What the Luna G3 APAP recall means

The U.S. Food and Drug Administration published a recall notice on September 8, 2026, for certain BMC Luna G3 APAP devices, Model LG3600. The issue is tied to firmware version G3-2.00.76, which can cause the machine to display an “Error” message and shut down automatically under a specific combination of high pressure, high respiratory rate, and high peak flow.

That shutdown can interrupt therapy. The FDA classifies the action as a Class I recall, and the agency says the firmware defect could result in serious adverse health consequences. BMC reported that it has received no complaints or serious adverse reports connected with this failure as of the recall notice.

The recall applies to devices distributed in the United States. It does not mean every Luna G3 APAP is affected, and the model name alone is not enough to determine whether a machine needs action.

Which Luna G3 devices are affected?

The affected product is the BMC Luna G3 APAP, Model LG3600, with firmware version G3-2.00.76. The FDA notice identifies two UDI numbers associated with the affected product: 06948538363331 and 06948538365892.

The devices involved were manufactured from September 11, 2024, through October 18, 2024. They were distributed nationwide in the United States between October 29, 2024, and July 6, 2026.

BMC says 20,160 devices had already been upgraded to firmware version G3-2.00.77 at the U.S. importer’s warehouse between October and December 2024. After the retrospective recall was reported, the company identified that as many as 196 units may not have received that upgrade.

Because the affected units are identified by serial number and firmware status, owners should use the official lookup rather than relying only on the purchase date, appearance, or model name.

How to check your Luna G3 APAP

Find the serial number on the label at the rear of the device. Then enter that number into BMC’s recall inquiry page and select the option to check the device. The lookup is intended to show whether the unit is affected and which firmware version is installed.

If the lookup is unavailable or you cannot read the label, contact your physician, durable medical equipment provider, or the U.S. importer, React Health. Ask them to confirm whether your specific Luna G3 APAP is safe to use and whether it requires replacement.

Do not guess based on a similar serial number, a retailer listing, or an online forum. The recall concerns a specific model, firmware version, and group of serial numbers.

What owners should do if the device has G3-2.00.76

The FDA-posted recall instructions say that devices operating with firmware version G3-2.00.76 should be discontinued immediately until a replacement device is provided. Contact React Health at 863-226-6285 or by email at 3B-Recall@reacthealth.com. The listed phone support hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. Eastern Time.

BMC also lists bmc-recall@bmc-medical.com for recall questions. When contacting support, have the device serial number, model number, prescribing provider information, and DME supplier details available if you have them.

If you depend on PAP therapy every night, contact your prescribing clinician or care team promptly about an interim plan. This article cannot determine whether another device, treatment schedule, or temporary alternative is appropriate for you.

What if the device is not affected?

If the official lookup confirms that your unit is not affected, save the result or note the firmware version for your records. Continue to follow the instructions from your care team and supplier.

A result showing firmware version G3-2.00.77 is different from the recalled G3-2.00.76 version identified in the FDA notice. If the result is unclear, contact React Health, BMC, your DME provider, or your physician rather than changing settings yourself.

What Canadian owners should know

The FDA notice describes devices distributed in the United States. Canadian owners should not assume that a U.S. recall notice automatically establishes the Canadian status of a device, particularly if the machine was purchased through a cross-border seller or received from a U.S. supplier.

Check the serial number with BMC and ask your Canadian supplier or sleep-care team for guidance. You can also search Health Canada’s medical device recall notices for any Canadian-specific communication. If your device was supplied in Canada, keep your purchase or rental records available when contacting the supplier.

How to report a problem

If the device displays an Error message, shuts down unexpectedly, or causes another suspected quality or safety problem, report it to the manufacturer or supplier. Consumers may also report medical product problems to the FDA through MedWatch.

Submit a report through FDA MedWatch ↗

Seek urgent medical help for severe or rapidly worsening symptoms. For routine recall questions, use the manufacturer, DME supplier, prescribing clinician, or FDA reporting channels listed above.

Current recall status as of September 10, 2026

The FDA recall notice remains the key U.S. source for the Luna G3 APAP Model LG3600 firmware issue. The notice does not provide a public deadline for checking a device or receiving a replacement. Owners with firmware G3-2.00.76 should contact React Health and their care team without waiting for a later update.

Helpful Links

• FDA Luna G3 APAP recall notice – Read the FDA-posted recall details, affected model information, risk description, and manufacturer contact instructions.
• BMC Luna G3 device inquiry page – Enter the serial number from the rear label of a Luna G3 APAP to check the device and firmware status.
• Health Canada medical device recalls – Search Canadian health product recall notices for country-specific information.
• FDA MedWatch reporting – Submit an online report about a suspected medical product problem or adverse event.

Frequently Asked Questions

Q. Does every BMC Luna G3 APAP have to be replaced?

A. No. The recall concerns certain Luna G3 APAP Model LG3600 devices with firmware version G3-2.00.76. Use the official serial-number lookup or ask React Health, your DME provider, or your care team to confirm the status of your specific unit.

Q. What does the Luna G3 firmware defect do?

A. Under simultaneous high pressure, high respiratory rate, and high peak flow, the affected device may display an Error message and shut down automatically. That can interrupt therapy.

Q. Can I update the recalled firmware myself?

A. The FDA-posted instructions direct owners with firmware G3-2.00.76 to discontinue the device until a replacement is provided. Do not attempt an unofficial firmware change or alter therapy settings without direction from the manufacturer, supplier, or prescribing care team.

Q. Is this recall for Canada too?

A. The FDA notice specifically concerns devices distributed in the United States. Canadian owners should confirm the status of their device with BMC, their supplier, or their sleep-care team and check Health Canada’s recall database for any Canadian-specific notice.

Q. Who should I contact about a recalled Luna G3 APAP?

A. React Health, the U.S. importer, lists 863-226-6285 and 3B-Recall@reacthealth.com for recall questions. BMC also lists bmc-recall@bmc-medical.com. Keep your device serial number available.