Class I — BMC Medical Co., Ltd.
| Recalling firm | BMC Medical Co., Ltd |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse |
| Product | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 |
| Quantity | 20,160 units |
| Distribution | US distribution to: FL OUS: None |
| Initiated | 2026-07-15 |
| Classified | 2026-08-19 |
| Recall number | Z-2979-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — BMC Medical Co., Ltd. (Z-2979-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99445/
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