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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Phasitron5 Breathing Circuits Recalled for Discolored Fluid and Nickel Coating

Agency Publication Date: October 30, 2024
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Summary

Percussionaire Corporation is recalling 43,830 Phasitron5 Breathing Circuits (models P5-10, P5-HC, and P5-UC-10) because of reports involving discolored fluid within the circuit. These breathing circuits are used during airway clearance therapy. The company found that an unapproved nickel coating on an internal spring can react with medicated mist, creating the discoloration. While no injuries have been reported, the company has received several complaints about the discolored fluid appearing during treatment.

Risk

The reaction between specific medications and the unapproved nickel coating can cause discolored fluid to enter the breathing circuit path. This poses a potential risk of chemical exposure or inhalation of metallic particles by the patient during respiratory therapy.

What You Should Do

  1. The recalled products are Phasitron5 Breathing Circuits (models P5-10, P5-HC, and P5-UC-10) used to provide airway clearance therapy.
  2. Check the lot number printed on your product packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Percussionaire Corporation or your authorized distributor to arrange for a return, replacement, or correction of the affected units.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10)
Model / REF:
P5-10
P5-HC
P5-UC-10
Lot Numbers:
240321
240329
240412
240430
240509
240516
240614
240625
240627

Component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95436
Status: Active
Manufacturer: Percussionaire Corporation
Sold By: Sentec AG; Authorized distributors
Manufactured In: United States
Units Affected: 43,830 devices
Distributed To: Pennsylvania, Arkansas, Michigan, California, Texas, Ohio, New York, Florida, Illinois, Nebraska, Oregon, Georgia, Wisconsin, Missouri, Oklahoma, Alabama, West Virginia, Montana, Colorado, Louisiana, Virginia, Connecticut, South Carolina, New Hampshire, Nevada, North Carolina, New Jersey, Utah, Idaho, Maine, Minnesota, South Dakota, North Dakota, Kansas, Kentucky, Tennessee, Maryland, Vermont, Massachusetts, Rhode Island

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.