FDA recall record · openFDA

Percussionaire Corporation

7 FDA recalls on record (2023–2025) — 7 device. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ve 2

Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may 1

Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affecte 1

As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy wa 1

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, 1

Recalls

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) Class I 2025-09-17 VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P Class I 2024-12-23 Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Val Class I 2024-08-21 Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve Class I 2024-08-21 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi Class I 2024-09-16 High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 Class I 2023-12-12 Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) Class I 2023-03-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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