Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency
Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified FDA Class I, which requires a minimum severity score of 4 per FDA guidelines for serious health hazards. While no illnesses or injuries have been reported, the labeling deficiency poses a risk to proper device function and patient therapy delivery.
Plain-English summary
Percussionaire Corporation has recalled 2523 units of its IPV (Intrapulmonary Percussive Ventilation) therapy in-line valve (REF: P5-TEE-20) due to a labeling deficiency. The FDA classified this as a Class I recall, indicating a serious potential health hazard.
The in-line valve includes a blue cap that must be removed prior to delivery and use of the device for IPV therapy. The original labeling did not adequately ensure this critical preparation step was communicated. Percussionaire Corporation has updated the labeling to clearly require removal of the blue cap before the device is delivered to or used by patients.
The recalled units were distributed nationwide in the United States and internationally to Israel, Japan, Russia, Switzerland, Canada, and Turkey. Affected units span multiple production lots and work orders.
Patients, healthcare facilities, and respiratory therapy providers who have received these devices should verify that the blue cap has been removed from the in-line valve before use. If you have received affected units, contact Percussionaire Corporation for guidance.
The recalled product
- Product
- Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
- Manufacturer
- Percussionaire Corporation
- Hazard
- improper-assembly
- device-malfunction
- respiratory-hazard
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27