Percussionaire Corporation medical device recall: Phasitron 5
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97374
- Recall initiated
- Sep 17, 2025
- Classified by FDA
- Oct 14, 2025
- Posted in Enforcement Report
- Oct 22, 2025
- Recalling firm
- Percussionaire Corporation
- Firm location
- Sandpoint, ID, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 17, 2025. FDA classified it 27 days later, on Oct 14, 2025. Distribution reported by FDA: Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE Percussionaire Corporation has 8 recalls in our records.
Recalled products (1)
Z-0031-2026 Class I Ongoing
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
Codes / lots: UDI-DI: 00849436000723. Lots: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756. Instructions for Use P20020 Rev F
Quantity: 59160
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97374
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.