Percussionaire Corporation: Device Recall
Recall #Z-0031-2026 · 09/17/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-0031-2026
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Percussionaire Corporation
- Status
- Ongoing
- Date Initiated
- 09/17/2025
- Location
- Sandpoint, ID, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59160
Reason for Recall
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.
Product Description
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Distribution Pattern
Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE
Other Recalls by Percussionaire Corporation
- Class I: Dangerous 12/23/2024
- Class I: Dangerous 09/16/2024
- Class I: Dangerous 08/21/2024
- Class I: Dangerous 08/21/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.