Use caution Medical device recall · FDA · Published September 17, 2025

Percussionaire Phasitron 5 In-Line Valve Recall: Risk of Respiratory Failure in Neonates

Percussionaire recalls Phasitron 5 In-Line Valves (P5-TEE-20/P5-TEE) that may leak when used with ventilators, risking respiratory failure in neonates or infants under 10kg with low tidal volumes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0031-2026Medical device Percussionaire ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmPercussionaire Corporation130 Mcghee Rd Ste 109 · Sandpoint, ID 83864-8409

✎ GovInfoNow plain-language explainer

Percussionaire is recalling Phasitron 5 In-Line Valves that could leak when connected to ventilators. This poses a risk of respiratory failure in neonates or infants under 10kg with low tidal volumes (less than 50mL). Read more at govinfonow.com/recall/51278-percussionaire-phasitron-5-in-line-valve-recall-risk-of-respiratory.

Source Summary by GovInfoNow · govinfonow.com/recall/51278-percussionaire-phasitron-5-in-line-valve-recall-risk-of-respiratory · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0031-2026

Cite this page

“Percussionaire Phasitron 5 In-Line Valve Recall: Risk of Respiratory Failure in Neonates.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51278-percussionaire-phasitron-5-in-line-valve-recall-risk-of-respiratory. Based on FDA recall #Z-0031-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0031-2026%22&limit=1).

The FDA announced on Sept. 17, 2025, that Percussionaire Corporation is recalling Phasitron 5 IPV In-Line Valves because the pressure relief seal may leak when used with a ventilator. Owners should stop using the devices immediately.

How to tell if you have it

Brand: Percussionaire
Product: Phasitron 5, IPV In-Line Valve (Intrapulmonary Percussive Ventilation)
REF: P5-TEE-20 (pack of 20) / P5-TEE (individual)
Lots: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756
Units affected: 59,160

The hazard

GovInfoNow's records show the leak may cause respiratory acidosis, hypoxemia, or respiratory failure. The hazard is particularly high for neonates, infants, or patients with target tidal volumes less than 50mL or weight less than 10kg due to unrecognized hypoventilation.

Context

GovInfoNow's records show Percussionaire Corporation has issued seven other recalls since Sept. 14, 2020. Other recent recalls of similar products include Medline Neonatal Breathing Circuits Risk of Sporadic Failure in Infants (July 13, 2026), Medline Hudson RCI Breathing Circuits Recall: Risk of Infant Respiratory Failure (July 13, 2026), and Medline Breathing Circuits Recall: Risk of Infant Breathing Failure (July 13, 2026).

How to tell if you have this one

Check for the Phasitron 5 In-Line Valve (P5-TEE-20 pack of 20 or P5-TEE individual) with UDI-DI: 00849436000723. These were sold in specific production lots from 2023 to 2025.

Brand
Percussionaire
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Valve Model
Identify if your valve is P5-TEE-20 (pack of 20) or P5-TEE (individual) with UDI-DI: 00849436000723.
Stop Using in High-Risk Patients
Do not use the valve with neonates or infants under 10kg who require tidal volumes less than 50mL.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 35 days after the firm started it.

Sep 17, 2025Firm started the recall
Oct 14, 2025FDA classified it Class I
Oct 22, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51278-percussionaire-phasitron-5-in-line-valve-recall-risk-of-respiratory">Percussionaire Phasitron 5 In-Line Valve Recall: Risk of Respiratory Failure in Neonates (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0031-2026 (September 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0031-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.