BMC/REACTHEALTH Luna G3 APAP REF LG 3600

FDA device recall Z-2979-2026 · posted 2026-08-19 · Open, Classified

Recall details

Recalling firm

BMC Medical Co., Ltd.

Reason for recall

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

Action taken

On July 17, 2026, BMC Health issued a retroactive "Urgent Medical Device Recall Notification" via Email. React Health ask consignees to take the following actions: 1. issue notification to all affected distributors 2. Review upgrade records 3. Confirm current distribution status 4. Perform Effectiveness Checks 5. Return Response Form. Should you have any questions regarding this Recall, you may contact Executive Vice President, R&D, Quality & Regulatory Affairs via the email address: Email: niuxiaomin@bmc-medical.com, 24 hours a day, Monday through Sunday.

Root cause

No Marketing Application

Status

Open, Classified

Product code

MNS

Quantity affected

20,160 units

Distribution

US distribution to: FL OUS: None

Date initiated

2026-07-15

Date posted

2026-08-19

Location

Beijing, China