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Open, Classified

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

FDA Recall Z-2979-2026 · Posted 2026-08-19

Recalling FirmBMC Medical Co., Ltd.
Recall StatusOpen, Classified
Product CodeMNS
Date Initiated2026-07-15
Product Quantity20,160 units

Reason for Recall

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

Firm Action

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: [email protected], 24 hours a day, Monday through Sunday.

Root Cause

No Marketing Application

Distribution Pattern

US distribution to: FL OUS: None

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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