Phasitron5 Breathing Circuit — Class I medical device recall Z-0208-2025
Ongoing recall by Percussionaire Corporation, reported 2024-11-06, distributed in AL, AR, CA, CO, CT, FL, GA, ID…. As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when
| Recall number | Z-0208-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Percussionaire Corporation, Sandpoint, ID, United States |
| Recall initiated | 2024-09-16 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV |
| Countries outside the US | CA, CH |
| Quantity | 43,830 devices |
| Reason classes | unapproved product |
| Lot numbers | 240321, 240329, 240412, 240430, 240509, 240516, 240614, 240625, 240627 |
| Model numbers | P5-10, P5-HC, P5-UC-10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0208-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.