Ventec Life Systems, Inc.
FDA Regulatory Profile
Ventec Life Systems, Inc. appears in FDA public data with 5 recalls — including 3 Class I (most serious) —, 1 510(k) clearance, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2525-2026, Class II) was initiated on May 8, 2026. Its most recent 510(k) clearance was granted on April 7, 2017.
Summary
- Total Recalls
- 5 (3 Class I)
- 510(k) Clearances
- 1
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2525-2026 | Class II | VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 | May 8, 2026 |
| Z-1942-2026 | Class I | VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 | March 25, 2026 |
| Z-1196-2025 | Class I | VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V | February 3, 2025 |
| Z-1070-2024 | Class I | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF P | January 9, 2024 |
| Z-1902-2021 | Class II | Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/ | May 10, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162877 | VOCSN Unified Respiratory System | April 7, 2017 |