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.
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.
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).
The in-line valve's pressure relief seal may leak when used with ventilators, causing respiratory acidosis, hypoxemia, or respiratory failure. This is especially dangerous for neonates and infants under 10kg with low tidal volumes (less than 50mL).
Healthcare providers using the Phasitron 5 In-Line Valves with ventilators are affected. Neonates and infants under 10kg with target tidal volumes less than 50mL are at highest risk.
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.
Identify if your valve is P5-TEE-20 (pack of 20) or P5-TEE (individual) with UDI-DI: 00849436000723.
Do not use the valve with neonates or infants under 10kg who require tidal volumes less than 50mL.
The valve's pressure relief seal may leak when used with ventilators, risking respiratory failure in neonates or infants under 10kg with low tidal volumes.
Check if your valve is P5-TEE-20 or P5-TEE with UDI-DI: 00849436000723. Do not use it with neonates or infants under 10kg requiring tidal volumes less than 50mL.
The recall does not specify a fix; the manufacturer recommends updates for continued use before design changes.
We’ve drafted a message you can send Percussionaire to request your refund or repair — edit it as you like.
Subject: Recall Z-0031-2026 — Percussionaire Percussionaire Hello, I own a Percussionaire that is covered by recall Z-0031-2026 from Percussionaire. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
