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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: IPV Therapy In-Line Valves Recalled for Safety Labeling Updates

Agency Publication Date: September 27, 2024
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Summary

Percussionaire Corporation is recalling approximately 52,983 IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valves, specifically models P5-TEE and P5-TEE-20. The recall was initiated because current labeling does not sufficiently emphasize that a blue cap on the valve must be removed before starting respiratory therapy. If the cap remains in place, it can block the delivery of air to the patient, which is a critical safety failure. Consumers should contact their healthcare provider or the manufacturer to receive updated safety instructions and labeling.

Risk

Failure to remove the blue cap from the in-line valve before starting therapy will completely block the patient's air passage. This can lead to a sudden lack of oxygen, respiratory distress, or other life-threatening medical emergencies.

What You Should Do

  1. Identify if you have Percussionaire IPV In-Line Valve models REF: P5-TEE or REF: P5-TEE-20.
  2. Check the device packaging for the following lot numbers: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, or WO03688.
  3. Ensure the blue cap on the in-line valve is completely removed before delivering any therapy to a patient.
  4. Contact Percussionaire Corporation at 130 Mcghee Rd Ste 109, Sandpoint, Idaho, to receive the corrected safety labeling and instructions for use.
  5. Consult your healthcare provider immediately if you have any questions regarding the safe use of this medical device.
  6. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Updated Labeling and Safety Instructions

How to: Contact the manufacturer or your healthcare provider for the updated labeling to ensure the blue cap is removed before therapy. Potential refund or exchange options should be discussed with the manufacturer.

Affected Products

Product: IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve (1-pack)
Model / REF:
P5-TEE
Lot Numbers:
240620
240610
240418
240326
230612
WO07066
WO07010
WO06020
WO05019
WO04884
WO04827
WO04756
WO04714
WO04656
WO04625
WO04596
WO04553
WO04398
WO04356
WO04061
WO03846
WO03748
WO03688
Product: IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve (20-pack)
Model / REF:
P5-TEE-20
Lot Numbers:
240620
240610
240418
240326
230612
WO07066
WO07010
WO06020
WO05019
WO04884
WO04827
WO04756
WO04714
WO04656
WO04625
WO04596
WO04553
WO04398
WO04356
WO04061
WO03846
WO03748
WO03688

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95239
Status: Active
Manufacturer: Percussionaire Corporation
Sold By: Medical equipment distributors; Hospitals
Manufactured In: United States
Units Affected: 2 products (50,460 units; 2523 units)
Distributed To: Nationwide

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.