Calyxo, Inc.
Calyxo, Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1396-2025, Class I) was initiated on February 19, 2025. Its most recent 510(k) clearance was granted on April 13, 2026.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1396-2025 | Class I | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examinatio | February 19, 2025 |