# FDA recall Z-0208-2025

> **Percussionaire Corporation** · Class I · device recall initiated 2024-09-16.

## Product

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

## Reason for recall

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.

## Distribution

U.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT, CO, LA, VA, CT, SC, NH, NV, NC, NJ, MI, UT, ID, ME, MN, SD, ID, ND, KS, KY, TN, MD, VT, MA, RI,   O.U.S.: Canada, Switzerland (all products shipped OUS remained in Sentec AG's (distributor, parent company of Percussionaire) control, were quarantined, and did not leave the warehouse).

## Key facts

- **Recall number:** Z-0208-2025
- **Recalling firm:** Percussionaire Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-16
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sandpoint, ID, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2025

## Citation

> AI Analytics. FDA recall Z-0208-2025. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0208-2025. Source: US FDA. Licensed CC0.

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