Recall Z-2979-2026 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BMC Medical Co., Ltd.
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
| Date | Aug 19, 2026 (initiated Jul 15, 2026) |
| Status | Open, Classified |
| Reason | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse |
| Root cause | No Marketing Application |
| 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: niuxiaomin@bmc-medical.com, 24 hours a day, Monday through Sunday. |
| Quantity | 20,160 units |
| Distribution | US distribution to: FL OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.