Bmc Medical Co., Ltd.: Ventilator, Continuous, Non-life-supporting

Recalling firm
BMC Medical Co., Ltd.
Product
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Reason
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-07-15
Status
Open, Classified
Areas affected
FL
Distribution
US distribution to: FL OUS: None

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/71afc3ad-bfed-4696-a3f0-efcba2de5a99