BMC Medical Co., Ltd.
BMC Medical Co., Ltd. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 6 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-2979-2026, Class I) was initiated on July 15, 2026. Its most recent 510(k) clearance was granted on August 14, 2026.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 1
Known Names
bmc medical co, bmc medical
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2979-2026 | Class I | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 | July 15, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | August 14, 2026 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | April 29, 2026 |
| K242935 | Respiration Data Management Software (PAP Link PC) | January 15, 2025 |
| K213169 | BPAP System | December 5, 2022 |
| K211155 | Auto CPAP System | March 9, 2022 |
| K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK | April 23, 2014 |