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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

Percussionaire Corporation: High Frequency Breathing Circuit Kits Recalled for Pressure Output Error

Agency Publication Date: January 17, 2024
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Summary

Percussionaire Corporation is recalling approximately 2,145 High Frequency Transport Phasitron Breathing Circuit Kits (REF: A50605-D) due to a mistake during the assembly process. This error can cause the breathing circuit to produce incorrect pressure levels, which can significantly affect the device's performance for patients. Consumers and medical staff should check their supply for affected lot numbers and contact the manufacturer or a healthcare provider for further guidance.

Risk

The assembly error affects the pressure output of the breathing circuit kit, which could result in inadequate ventilation or oxygenation for the patient. This defect poses a risk of severe health impacts to individuals who rely on the device for respiratory support.

What You Should Do

  1. Identify your product by checking for the High Frequency Transport Phasitron Breathing Circuit Kit, REF: A50605-D, with UDI (01)10849436000331.
  2. Check the packaging for the following affected lot numbers: WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930, or WO06028.
  3. If you possess a kit from an affected lot, contact Percussionaire Corporation or your healthcare provider immediately to discuss safety and obtain further instructions.
  4. Contact Percussionaire Corporation at their Sandpoint, Idaho facility (130 Mcghee Rd Ste 109) for specific details regarding replacement or corrective actions for these kits.
  5. Contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D
Model / REF:
A50605-D
Lot Numbers:
WO05216
WO05254
WO05321
WO05392
WO05559
WO05588
WO05684
WO05749
WO05896
WO05930
WO06028

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93476
Status: Active
Manufacturer: Percussionaire Corporation
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 2145 units
Distributed To: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, Tennessee, Texas, Utah, Virginia

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.