Facility

PERCUSSIONAIRE CORP.

7 recall(s) on record — most severe on record: Class I.

Key facts

7recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000524541
Establishment type	Manufacture Medical Device
Location	130 MCGHEE RD STE 109 SANDPOINT, ID, US 83864
Registration status	Active · expires 2026
Parent company	PERCUSSIONAIRE CORP. (owner-operator 9029650)
Brand names	IPV Percussionator Family and Acc

Activity by year

Recalls (7)
Inspections (3)

Devices registered here (1)

Device, Positive Pressure Breathing, Intermittent
Product code NHJ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5905

Recalls & enforcement

Class IOngoing2025-09-17
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 f…
Class IOngoing2024-12-23
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.
Class IOngoing2024-09-16
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 ad…
Class IOngoing2024-08-21
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Class IOngoing2023-12-12
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
Class IOngoing2023-03-28
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Class IICompleted2020-09-14
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.

FDA inspections (3)

VAI2024-08-22
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-08-25
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-03-24
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by PERCUSSIONAIRE CORP.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PERCUSSIONAIRE CORP. (FEI 1000524541) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000524541-percussionaire-corp/

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