FDA-Device2026-08-26Class IPROCESSING DEFECT
BMC Luna G3 APAP devices recalled for retroactive warehouse rework reporting
What this means
BMC Medical Co., Ltd. is reporting retroactive rework that was conducted on Luna G3 APAP devices at the 3B/React Health warehouse in 2024. This retroactive reporting involves approximately 20,160 units with specific serial numbers.
- Check if your device serial number matches the affected list (contact BMC or your supplier with your device serial number)
- Contact BMC Medical Co., Ltd. or your healthcare provider for guidance on your specific device
- Do not discard your device without instructions from the manufacturer
The agency's original wording
Hazard
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to: FL OUS: None
Affected count
20,160 units
Manufactured in
Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road Fengtai District, Beijing, China
Products
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2979-2026More BMC Medical recalls
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