Lower risk Medical device recall · FDA · Published September 16, 2024

Percussionaire Phasitron5 Breathing Circuit Recall: Discolored Fluid Risk

Percussionaire recalls Phasitron5 Breathing Circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid from nickel coating reactions with medication. Affected units sold with specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0208-2025Medical device Percussionaire ›

Lower-risk 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.

Take action

Contact the company

Recalling firmPercussionaire Corporation130 Mcghee Rd Ste 109 · Sandpoint, ID 83864-8409

✎ GovInfoNow plain-language explainer

Percussionaire is recalling Phasitron5 Breathing Circuits (P5-10, P5-HC, P5-UC-10) because they can develop discolored fluid when used with certain medications. This reaction involves a nickel coating on the spring component, which may cause issues during airway clearance therapy. Read more at govinfonow.com/recall/54020-percussionaire-phasitron5-breathing-circuit-recall-discolored-fluid-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54020-percussionaire-phasitron5-breathing-circuit-recall-discolored-fluid-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0208-2025

Cite this page

“Percussionaire Phasitron5 Breathing Circuit Recall: Discolored Fluid Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54020-percussionaire-phasitron5-breathing-circuit-recall-discolored-fluid-risk. Based on FDA recall #Z-0208-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2025%22&limit=1).

The FDA announced on Sept. 16, 2024, that Percussionaire Corporation is recalling Phasitron5 Breathing Circuits due to discolored fluid forming during therapy. The agency said the discoloration results from a reaction between medicated mist and an unapproved nickel coating on a spring component.

How to tell if you have it

Brand: Percussionaire
Product: Phasitron5 Breathing Circuit
Model Numbers: P5-10, P5-HC, P5-UC-10
Lot Codes: 240321, 240329, 240412, 240430, 240509, 240516, 240614, 240625, 240627
Units Affected: 43,830 devices

The hazard

The FDA said breathing circuits are experiencing discolored fluid when therapy is given with specific medication through the nebulizer cup. This discoloration is caused by a reaction between medicated mist and an inadvertent or unapproved addition of a nickel coating on the spring component.

Context

GovInfoNow's records show Percussionaire Corporation has had seven other recalls since Sept. 14, 2020. Other recent recalls include an Intrapulmonary Percussive Ventilation labeling update (Aug. 18, 2026), a Phasitron 5 In-Line Valve risk of respiratory failure (Sept. 17, 2025), and a VDR4 Breathing Circuit venturi stuck risk (Dec. 23, 2024). Other recent recalls of similar products include Medline Medical Kits particulate in fluid path risks (March 24, 2026) and Hillrom VOLARA System P.CIRCUIT 5KIT AC oxygen leakage risk (May 21, 2026).

How to tell if you have this one

Check for Phasitron5 Breathing Circuits with model numbers P5-10, P5-HC, or P5-UC-10. Affected units have lot numbers 240321, 240329, 240412, 240430, 240509, 240516, 240614, 240625, or 240627.

Brand
Percussionaire
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Identify your Phasitron5 Breathing Circuit model number (P5-10, P5-HC, or P5-UC-10) and lot number from the product label.

Where it went and when

Where it was distributed

Distributed in 40 states, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 51 days after the firm started it.

Sep 16, 2024Firm started the recall
Oct 30, 2024FDA classified it Class I
Nov 6, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Percussionaire recalls

Link to this recall

<a href="https://govinfonow.com/recall/54020-percussionaire-phasitron5-breathing-circuit-recall-discolored-fluid-risk">Percussionaire Phasitron5 Breathing Circuit Recall: Discolored Fluid Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0208-2025 (September 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0208-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.