Percussionaire Corporation

Complete recall history across all FDA and CPSC categories — 8 total recalls

Percussionaire Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Percussionaire Corporation

Date Product Reason Class
Sep 17, 2025 Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: ... IFU update; in-line valve, with pressure relief seal may leak when used with ... Class I
Dec 23, 2024 VDR4 Phasitron Breathing Circuit Models that contain the venturi component: ... Due to internal venturi component getting transiently stuck in the forward po... Class I
Sep 16, 2024 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulm... As a result of product complaints, breathing circuits are experiencing discol... Class I
Aug 21, 2024 Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Perc... Updated labeling to ensure that blue cap on in-line valve is removed, prior t... Class I
Aug 21, 2024 Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... Updated labeling to ensure that blue cap on in-line valve is removed, prior t... Class I
Dec 12, 2023 High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx On... Due to an assembly error within the breathing circuit, their pressure output ... Class I
Mar 28, 2023 Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control dri... Breathing circuit reservoir bag may be assembled at the wrong attachment poin... Class I
Sep 14, 2020 Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. Note this recall occurred in 2020 and 2021. Reports of screen freeze on visua... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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