Recall archive / FDA device enforcement
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to pr... — FDA record Z-0208-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Percussionaire Corporation
- Quantity
- 43,830 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0208-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627 |
Match all identifying details in the current notice. A brand name alone is not enough.
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).
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Idaho
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Nov 6, 2024
- Recall initiation date
- Sep 16, 2024
- Center classification date
- Oct 30, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.