CLASS I ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) recalled
Percussionaire is recalling Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10), distributed in 40 states. The recall was initiated on 16 Sep 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0208-2025
- FDA event ID
- 95436
- Recalling firm
- Percussionaire, Sandpoint, ID
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 Sep 2024
- FDA classified
- 30 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Sep 2024 | Recall initiated by company | |
| 30 Oct 2024 | Classified by FDA | +44 days |
| 6 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Where it was distributed
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).
AlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Is Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) recalled?
Yes. Percussionaire recalled Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) on 16 Sep 2024. The recall is Class I and its status is Ongoing. Recall number Z-0208-2025.
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.
Which lots are affected?
Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627
Where was it sold?
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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Percussionaire
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Phasitron 5, IPV In-Line Valve recalled by Percussionaire | Percussionaire | Packaging Defects | Nationwide |
| Device | CLASS I | VDR4 Phasitron Breathing Circuit recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS I | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV recalled | Percussionaire | Other | Nationwide |
| Device | CLASS I | Percussionaire, Inc., REF: P5-Tee-20, Qty: 20, Rx Only. IPV recalled | Percussionaire | Other | Nationwide |
| Device | CLASS I | Distal Phasitron, Part: S20020, for use recalled by Percussionaire | Percussionaire | Other | CA, RI, TX |
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