Percussionaire Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 8 (7 Class I)
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0031-2026 | Class I | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ | September 17, 2025 |
| Z-0960-2025 | Class I | VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitro | December 23, 2024 |
| Z-0208-2025 | Class I | Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventil | September 16, 2024 |
| Z-3207-2024 | Class I | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) the | August 21, 2024 |
| Z-3208-2024 | Class I | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) | August 21, 2024 |
| Z-0637-2024 | Class I | High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 | December 12, 2023 |
| Z-0693-2024 | Class I | Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) | March 28, 2023 |
| Z-0259-2024 | Class II | Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. | September 14, 2020 |