FDA Medical devices recall ·
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0208-2025
- Date
- (initiated September 16, 2024)
- Company / brand
- Percussionaire Corporation
130 Mcghee Rd Ste 109, Sandpoint, ID, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 43,830 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627
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: 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
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0208-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.