FDA recall Z-2979-2026
BMC Medical Co., Ltd. · Class I · device
Product
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Reason for recall
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Distribution
US distribution to: FL OUS: None
Key facts
- Status
- Ongoing
- Initiation date
- 2026-07-15
- Report date
- 2026-08-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Beijing, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2979-2026