Recall Z-3319-2026— Percussionaire Corporation
Class II · Ongoing
Class II FDA medical device recall by Percussionaire Corporation, initiated 2026-08-18. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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, awareness during anesthesia, oversedation.
- Recalling firm
- Percussionaire Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-18
- Firm location
- Sandpoint, ID, United States
Product description
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
Reason for recall
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, awareness during anesthesia, oversedation
Data sourced from openFDA. This site is unofficial and independent of the FDA.