Intrapulmonary Percussive Ventilation, IPV HC, Product… recallZ-3325-2026 · Percussionaire Corporation · initiated Aug 18, 2026

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

On 8/18/2026, correction notices were emailed to customers and distributors who were informed of the following: The following warning will be added to associated Instructions for Use: Warning: Do not use IPV therapy in conjunction with volatile anesthetic delivery systems. The high-frequency percussive flow generated during IPV therapy may alter the controlled delivery of volatile anesthetic agents within the breathing circuit, resulting in unpredictable anesthetic agent concentrations that may result in serious patient harm. Note: Consult the anesthesia healthcare provider before disconnecting from the system if considering delivering IPV directly to the patient's airway. Customers were asked to do the following: 1) Print and post the new warning for applicable IPV devices throughout your facility to ensure adequate distribution of new information to users. 2) Reinforce adherence to the IPV User Guide and IPV Quick Reference Guide instructions, including ensuring communication and training primary users of IPV therapy, specifically those using it in-line with a ventilator, on the instructions and new warning. Distributors were asked to do the following: - Translate (if applicable) and send the Urgent Medical Device Field Safety Notice to affected end customers. -If the Distributor receives the signed acknowledgement letters from affected customers, please forward them and all related communication to [email protected]. If there are any additional questions related to the updated instructions or other questions, please contact [email protected]

Recall details

Recall number

Z-3325-2026

Status

Open, Classified

Initiated by the company

Aug 18, 2026

Posted by the FDA

Sep 28, 2026

Recalling firm

Percussionaire Corporation

Quantity

419

Product code

NHJ

Distribution

Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI 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.

Product description

Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Percussionaire F00012-HT

  Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent
  1 recall0 reports
• Percussionaire P5-HC

  Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99617).

• Z-3319-2026 · Open, Classified
  Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruct…
• Z-3320-2026 · Open, Classified
  In-Line Valve, Product Number: P5-TEE
• Z-3321-2026 · Open, Classified
  Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
• Z-3322-2026 · Open, Classified
  Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
• Z-3323-2026 · Open, Classified
  Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
• Z-3324-2026 · Open, Classified
  Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual