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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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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Pulmonx, Corp.: Zephyr Endobronchial Valves Recalled for Incorrect Expiration Dates

Agency Publication Date: November 6, 2023
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Summary

Pulmonx, Corp. is recalling 144 units of the Zephyr Endobronchial Valve (EBV) 5.5-LP because they were labeled with an incorrect, shortened expiration date. While the labels may suggest the product has expired sooner, the manufacturer has confirmed these specific implant devices are safe for use until their true expiration date of December 8, 2024. These devices were distributed across 22 states including California, Texas, and Florida.

Risk

The primary risk is potential confusion or clinical delays if a healthcare provider believes a device is expired when it is actually still valid for use. Using a device past its true expiration could compromise sterility or mechanical integrity, though in this specific case, the manufacturer has verified the devices remain safe through the corrected date.

What You Should Do

  1. Identify if you have the Zephyr Endobronchial Valve (EBV) 5.5-LP, reference number EBV-TS-5.5-LP, by checking the packaging for UDI (01)00811907030423(10)506590V70(17)241208.
  2. Check the product label for Lot number 506590-V7.0 (or 506590-V7).
  3. Verify the expiration date on your current inventory; if it shows a date earlier than December 2024, note that the correct and safe expiration date for these specific lots is 08 December 2024.
  4. Contact your healthcare provider or Pulmonx, Corp. at their Redwood City, California headquarters for further instructions regarding updated labeling or potential device replacement.
  5. Contact the FDA for additional questions or to report issues at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Corrected Expiration Date Information

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

Affected Products

Product: Zephyr Endobronchial Valve (EBV) 5.5-LP
Model / REF:
EBV-TS-5.5-LP
Lot Numbers:
506590-V7.0
506590-V7
Date Ranges: 08 December 2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93179
Status: Active
Manufacturer: Pulmonx, Corp.
Sold By: Specialty medical distributors; Hospitals
Manufactured In: United States
Units Affected: 144
Distributed To: Tennessee, West Virginia, Arkansas, Pennsylvania, Virginia, North Carolina, Illinois, Iowa, Massachusetts, New York, New Jersey, Washington, Colorado, Oregon, Michigan, Florida, Ohio, Texas, Oklahoma, Arizona, Nevada, Wisconsin

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.