Percussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
Percussionaire Corporation is recalling IPV-2C and Phasitron 5 devices to update labeling warnings regarding the use of these devices with volatile anesthetic delivery systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling update to prevent potential adverse effects without reporting specific hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Percussionaire Corporation is recalling 229,430 units of Intrapulmonary Percussive Ventilation (IPV) devices, specifically the IPV-2C (Product Number: S00002-C) and Phasitron 5 (Product Number: P5), along with their associated Instruction Manuals. The recall is being conducted to update labeling to include a warning against using IPV in conjunction with volatile anesthetic delivery systems.
The updated warning is necessary because the use of IPV with these systems may alter the controlled delivery of volatile anesthetic agents. This alteration can result in deeper or lighter anesthetic effects, which may lead to hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.
The affected products were distributed worldwide, including nationwide in the United States and in numerous countries such as Canada, the United Kingdom, Germany, and Australia. Users of these devices should review the updated labeling and discontinue the use of IPV with volatile anesthetic delivery systems until the warning is acknowledged.
The recalled product
- Product
- Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- Manufacturer
- Percussionaire Corporation
- Category
- Medical Device — Ventilation
- Affected units
- 229,430
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 (7)
- Product Number/UDI-DI: S00002-C/00849436000020
- 00849436000563
- 00849436000570
- 00849436000143
- 00849436000648
- P5/00849436000501
- Instruction Manual: P20046 Rev A
Distribution
Related recalls
Same manufacturer · Percussionaire Corporation
See all →- HighPercussionaire In-Line Valve Recalled for Anesthetic Delivery Warning
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- HighPercussionaire Impulsator and Phasitron 5 Recall for Anesthesia Warning Update
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- HighPercussionaire Travel Air and Phasitron 5 Recall for Anesthetic Warning
FDA (Devices) · 2026-10-07
Same hazard · mis labeling
See all →- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateAdmiral Beverage Recalls 7up Tropical Cans with Undeclared Sugar
FDA (Food) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07