VDR4 Phasitron Breathing Circuit Recalled for Potential Ventilation Reduction
Percussionaire Corporation is recalling VDR4 Phasitron breathing circuit models due to a venturi component that may stick and reduce ventilation. This Class I recall affects over 4,700 units worldwide.
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 is a Class I FDA medical device recall, which per regulatory standards requires a minimum Severe classification. While no illnesses or injuries are reported in the source text, the potential for reduced ventilation in a breathing circuit poses a significant patient safety risk.
Plain-English summary
The VDR4 Phasitron breathing circuit is a medical device manufactured by Percussionaire Corporation that is intended for continuous ventilation of patients. This recall affects multiple models and kits, including the Phasitron Kit (Model A50094-D-5PK), Control Unit Tester (Model A51001), VDR W/Swivel T Single Patient Phasitron (Model PRT 991), VDR4 Humidification Adapter Kit (Model PRT 992), and VDR4 Humidification Kit with Cross Tee (Model PRT 993).
The FDA has initiated a Class I recall because the internal venturi component within the breathing circuit may become transiently stuck in the forward position. When this occurs, it can cause a reduction in the amplitude and volume of ventilation being delivered to patients.
Approximately 4,727 packs or cases have been distributed worldwide. Within the United States, affected devices were distributed to Arizona, Florida, Illinois, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Rhode Island, Texas, Utah, and West Virginia. Internationally, the devices reached Belgium, Canada, France, Hong Kong, the Netherlands, Russia, Switzerland, and Turkey.
Customers currently using these devices should immediately stop use and contact Percussionaire Corporation for further instructions regarding the recall.
The recalled product
- Product
- VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT
- Manufacturer
- Percussionaire Corporation
- Hazard
- ventilation-reduction
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- -Phasitron Kit
- VDR
- Single Patient
Distribution
Distributed nationwide across the United States.
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