ANNOUNCED ONGOING Device recall · Reported 8 Sep 2026 · FDA company announcement, classification pending
BMC Luna G3 APAP recalled by BMC Medical
BMC Medical is recalling BMC Luna G3 APAP (, distributed nationwide in the US. The recall was initiated on 7 Sep 2026 and is listed as ongoing.
Recall details
- Recall number
- FDA-PR-cca93344a0a2
- Recalling firm
- BMC Medical
- Brand
- BMC
- Classification
- Pending
- Status
- Ongoing
- Recall initiated
- 7 Sep 2026
- Reported
- 8 Sep 2026
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 7 Sep 2026 | Recall initiated by company | |
| 8 Sep 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect. On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers. On August 19, 2026, the FDA classified this retrospective recall as a Class I recall (FDA Recall Number: Z-2979-2026). BMC has identified that firmware version, G3-2.00.76 installed on these Luna G3 APAP (Model LG3600) devices contained a firmware defect. BMC conducted a firmware upgrade of these devices to version G3-2.00.77 for 20,160 affected devices at the U.S. importer’s warehouse from October through December 2024. After reporting the retrospective recall, BMC discovered that potentially up to 196 units did not receive the upgrade and identified that these devices may still contain firmware version G3-2.00.76. If the affected device(s) operates simultaneously under high pressure, high respiratory rate, and high peak flow an "Error" message on the device display is triggered, followed by automatic shutdown resulting in a failure to deliver therapy. The firmware defects could result in unintended serious adverse health consequences. To date, BMC has received no complaints or serious adverse reports associated with this firmware failure. Impacted products were manufactured from September 11, 2024, to October 18, 2024, and distributed by BMC to its U.S. importer, React Health (RH)
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the company
BMC Luna G3 APAP (Model LG3600)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect. On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers. On August 19, 2026, the FDA classified this retrospective recall as a Class I recall (FDA Recall Number: Z-2979-2026). BMC has identified that firmware version, G3-2.00.76 installed on these Luna G3 APAP (Model LG3600) devices contained a firmware defect. BMC conducted a firmware upgrade of these devices to version G3-2.00.77 for 20,160 affected devices at the U.S. importer’s warehouse from October through December 2024. After reporting the retrospective recall, BMC discovered that potentially up to 196 units did not receive the upgrade and identified that these devices may still contain firmware version G3-2.00.76. If the affected device(s) operates simultaneously under high pressure, high respiratory rate, and high peak flow an "Error" message on the device display is triggered, followed by automatic shutdown resulting in a failure to deliver therapy. The firmware defects could result in unintended serious adverse health consequences. To date, BMC has received no complaints or serious adverse reports associated with this firmware failure. Impacted products were manufactured from September 11, 2024, to October 18, 2024, and distributed by BMC to its U.S. importer, React Health (RH)
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does an unclassified recall mean?
The FDA assigns a class once it has assessed the health risk. Until then the recall is listed without one.
Read the official FDA notice · Source record retrieved 26 Sep 2026. This is a company announcement published by the FDA; the FDA has not yet classified the recall. The record is updated when the classification appears in the Enforcement Report. This page reports the record and gives no medical advice.
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