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Percussionaire Corporation FDA Recalls
7 recalls on file across devices, 7 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual)Class ISep 17, 2025IFU update; in-line valve, with pressure relief seal may lea |
| VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single PClass IDec 23, 2024Due to internal venturi component getting transiently stuck |
| Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to proviClass ISep 16, 2024As a result of product complaints, breathing circuits are ex |
| Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line ValClass IAug 21, 2024Updated labeling to ensure that blue cap on in-line valve is |
| Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line ValveClass IAug 21, 2024Updated labeling to ensure that blue cap on in-line valve is |
| High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123Class IDec 12, 2023Due to an assembly error within the breathing circuit, their |
| Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)Class IMar 28, 2023Breathing circuit reservoir bag may be assembled at the wron |