Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits
Reason given by FDA: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Percussionaire Corporation recalled multiple intrapulmonary percussive ventilation products, including the Impulsator, IPV 1, IPV-1C, IPV-2C, IPV HC, Travel Air, and In-Line Valve, because labeling was updated to warn against use with volatile anesthetic delivery systems. The FDA added the recall to its Enforcement Report on September 28, 2026, and the company began the recall on August 18, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
7 products
Match the UDI-DI and product code listed under your product.
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
- UDI-DI
- 00849436000679
- 00849436000709
- 00849436000686
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- UDI-DI
- 00849436000020
- 00849436000563
- 00849436000570
- 00849436000143
- 00849436000648
- 00849436000501
In-Line Valve
- UDI-DI
- 00849436000723
- Product code
- P5-TEE
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
- UDI-DI
- 00849436000389
- 00849436000501
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- UDI-DI
- 00849436000020
- 00849436000563
- 00849436000570
- 00849436000143
- 00849436000648
- 00849436000501
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
- UDI-DI
- 00849436000358
- 00849436000525
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
- UDI-DI
- 00849436000242
- 00849436000501
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of California, Pennsylvania, Oklahoma, Georgia, Texas, Ohio, Wisconsin, Washington, New York, Missouri, Florida, Delaware, Louisiana, South Carolina, West Virginia, New Jersey, Nebraska, Kansas, North Carolina, Alabama, Colorado, Virginia, Oregon, Arizona, Illinois, Connecticut, Idaho, New Hampshire, Utah, Tennessee, Maryland, Vermont, Mississippi, Nevada, District of Columbia, Maine, Iowa, Arkansas, Hawaii, North Dakota, Indiana, Montana, New Mexico, Minnesota, Michigan, South Dakota, Massachusetts, Alaska, Rhode Island and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.
- Event ID
- 99617
- Recall numbers
- Z-3319-2026 to Z-3325-2026
- Company
- Percussionaire CorporationSandpoint, Idaho
- Hazard
- Labeling error
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
