Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Phasitron5 Breathing Circuit (P5-10 Recalled by Percussionaire Corporation Due to As a result of product complaints, breathing circuits...

Date: September 16, 2024
Company: Percussionaire Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Percussionaire Corporation directly.

Affected Products

Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

Quantity: 43,830 devices

Why Was This Recalled?

As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.

Where Was This Sold?

This product was distributed to 40 states: AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WI

Affected (40 states)Not affected

About Percussionaire Corporation

Percussionaire Corporation has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report