Percussionaire recalls

8 official recalls and safety alerts involving Percussionaire since 2023-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Percussionaire or the relevant agency.

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Percussionaire Corporation recalls Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

    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,…

    FDA · DevicePercussionaire CorporationWorldwide - US Nationwide distribution including in the states of CA, PA, OK,…Official notice →
  3. 2025-10-22
  4. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line…

    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…

    FDA · DevicePercussionaire CorporationWorldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada,…Official notice →
  5. 2025-01-29
  6. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk…

    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.

    FDA · DevicePercussionaire CorporationWorldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO,…Official notice →
  7. 2024-11-06
  8. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway…

    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…

    FDA · DevicePercussionaire CorporationU.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT,…Official notice →
  9. 2024-10-09
  10. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

    Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

    FDA · DevicePercussionaire CorporationUS: Nationwide OUS: Israel Japan Russia Switzerland Canada TurkeyOfficial notice →
  11. 2024-01-24
  12. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

    Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

    FDA · DevicePercussionaire CorporationUS: RI, CA, TXOfficial notice →
  13. US
    Drugs & medicalClass I

    Percussionaire Corporation recalls High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

    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

    FDA · DevicePercussionaire CorporationUS:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: NoneOfficial notice →
  14. 2023-11-15
  15. US
    Drugs & medicalClass II

    Percussionaire Corporation recalls Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

    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…

    FDA · DevicePercussionaire CorporationUS: CA, ND, MS, MDOfficial notice →