Sandpoint, ID, United States
Percussionaire Corporation recalls
8 recalls recorded since 2018, most recently on 18 August 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)7
Terminated or completed1
Class I (FDA)6
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3325-2026, Z-3322-2026, Z-3320-2026, Z-3323-2026, Z-3324-2026, Z-3321-2026, Z-3319-2026
- Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
- Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- In-Line Valve, Product Number: P5-TEE
- Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
- Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
- Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
Ongoing Class I Medical devices
- Recall started
- 17 September 2025
- Reason
- 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.
- Distribution
- Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0031-2026
- Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Ongoing Class I Medical devices
- Recall started
- 23 December 2024
- Reason
- 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.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0960-2025
- VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON
Ongoing Class I Medical devices
- Recall started
- 16 September 2024
- Reason
- 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.
- Distribution
- U.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT, CO, LA, VA, CT, SC, NH, NV, NC, NJ, MI, UT, ID, ME, MN, SD, ID, ND, KS, KY, TN, MD, VT, MA, RI, O.U.S.: Canada, Switzerland (all products shipped OUS remained in Sentec AG's (distributor, parent company of Percussionaire
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0208-2025
- Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Ongoing Class I Medical devices
- Recall started
- 21 August 2024
- Reason
- Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
- Distribution
- US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3208-2024, Z-3207-2024
- Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
- Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Ongoing Class I Medical devices
- Recall started
- 12 December 2023
- Reason
- 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
- Distribution
- US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0637-2024
- High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Ongoing Class I Medical devices
- Recall started
- 28 March 2023
- Reason
- Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- Distribution
- US: RI, CA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0693-2024
- Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Completed Class II Medical devices
- Recall started
- 14 September 2020
- Reason
- 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.
- Distribution
- US: CA, ND, MS, MD
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0259-2024
- Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.