Recall Z-2979-2026— BMC Medical Co., Ltd.

Class I · Ongoing

Class I FDA medical device recall by BMC Medical Co., Ltd., initiated 2026-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: BMC/REACTHEALTH Luna G3 APAP REF LG 3600. Reason: Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse.

Recalling firm
BMC Medical Co., Ltd.
Classification
Class I
Status
Ongoing
Initiated
2026-07-15
Firm location
Beijing, China

Product description

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Reason for recall

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Data sourced from openFDA. This site is unofficial and independent of the FDA.