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Percussionaire Recalls
8 recalls on record · November 15, 2023 to October 22, 2025 · Medical Devices
Recalls by year
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 22, 2025Medical DevicesFDA
Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual)
Hazard: IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
January 29, 2025Medical DevicesFDA
Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P
Hazard: Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
November 6, 2024Medical DevicesFDA
Percussionaire Corporation recalls Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi
Hazard: As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
October 9, 2024Medical DevicesFDA
Percussionaire Corporation recalls Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Val
Hazard: Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
October 9, 2024Medical DevicesFDA
Percussionaire Corporation recalls Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Hazard: Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
January 24, 2024Medical DevicesFDA
Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Hazard: Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
January 24, 2024Medical DevicesFDA
Percussionaire Corporation recalls High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Hazard: Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
November 15, 2023Medical DevicesFDA
Percussionaire Corporation recalls Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Hazard: Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.