Quick Facts at a Glance
- Recall Date
- September 17, 2025
- Hazard Level
- HIGH
- Brand
- Percussionaire
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- INFANTS, PREGNANT, GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Percussionaire
- Product type
- IPV In-Line Valve (Intrapulmonary Percussive Ventilation)
- Model numbers
- P5-TEE-20, P5-TEE, UDI-DI: 00849436000723, 240326, 250116, 240418, 250324, 240610 +13 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 17, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Percussionaire Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
The Phasitron 5 IPV In-Line Valve is used in intrapulmonary percussive ventilation systems. It is integrated into medical devices used by patients needing respiratory support.
Why This Is Dangerous
A leaked valve during ventilation can cause inadequate ventilation leading to respiratory acidosis, low oxygen levels, and potential respiratory failure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall affects patients and healthcare providers worldwide who rely on this component for ventilation. Immediate action could prevent serious complications and potential life-threatening outcomes.
Practical Guidance
How to identify if yours is affected
- Identify models P5-TEE-20 and P5-TEE and cross-check UDI-DI 00849436000723.
- Consult your hospital's biomedical engineering department for verification.
Where to find product info
Use the FDA recall page linked in enforcement reports for official identifiers and instructions.
What timeline to expect
Recall remedy is via manufacturer instructions and notification by letter. Specific replacement or refund timing is not provided.
If the manufacturer is unresponsive
- Escalate to hospital risk management or regulatory authority.
- Document all communications with the manufacturer.
How to prevent similar issues
- In future, verify device recalls through FDA and manufacturer updates prior to implant or use.
- Maintain updated IFUs and ensure staff are trained on gear changes.
- Ensure strict ventilator compatibility checks with inline valves.
Documentation advice
Keep copy of recall letter, authenticate device IDs, photograph labels, record communications with manufacturers and clinicians.
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Product Details
Model numbers include P5-TEE-20 and P5-TEE. UDI-DI 00849436000723. Additional model codes: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756. Worldwide distribution with US nationwide and other countries listed in the recall.
Reported Incidents
No specific incident counts are provided in the source document.
Key Facts
- IFU update as root cause
- Leak potential with ventilators
- Hazardous for neonates/infants or <10 kg or <50 mL tidal volumes
- Class I recall
- Worldwide distribution including US, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa,
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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