Focalyx Technologies, LLC.
Focalyx Technologies, LLC. appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1243-2026, Class II) was initiated on December 23, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1243-2026 | Class II | Focalyx Fusion | December 23, 2025 |