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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/Diagnostic Equipment

Lucid Diagnostics, Inc.: EsophaCap Sponges Recalled Due to Risk of Detachment During Removal

Agency Publication Date: May 24, 2024
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Summary

Lucid Diagnostics, Inc. is recalling 377 units of EsophaCap sponges because the sponge may detach from its string while being removed from a patient. The detachment is most likely to occur at the narrowest parts of the throat, such as the upper or lower esophageal sphincters. This recall includes models EC20T20VI and EC25T10VI that were distributed to clinical sites in Minnesota and Maryland or held at distributors.

Risk

If the sponge detaches from the string during removal, it may remain lodged in the patient's esophagus or throat. This creates a choking hazard or may require an additional medical procedure to retrieve the sponge safely.

What You Should Do

  1. Identify if you have the affected EsophaCap sponges by checking the package for Model/Catalog numbers EC20T20VI (20mm) or EC25T10VI (25mm).
  2. Check the GTIN and Lot numbers on your supply: For the 20mm model (EC20T20VI, GTIN 00860007510953), look for Lot numbers 462, 486, 501, or 540.
  3. For the 25mm model (EC25T10VI, GTIN 00860007510977), check for Lot numbers 483, 502, or 539.
  4. If you have any of these affected lots, stop using the devices immediately and secure them in a safe location.
  5. Contact your healthcare provider or Lucid Diagnostics, Inc. for further instructions regarding the return or disposal of the affected units and potential replacement or refund options.
  6. For more information or to report a problem, contact the FDA 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

Contact for instructions

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

Affected Products

Product: EsophaCap (20mm diameter, 20 pores/inch)
Model / REF:
EC20T20VI
UPC Codes:
00860007510953
Lot Numbers:
462
486
501
540
Product: EsophaCap (25mm diameter, 10 pores/inch)
Model / REF:
EC25T10VI
UPC Codes:
00860007510977
Lot Numbers:
483
502
539

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94510
Status: Active
Manufacturer: Lucid Diagnostics, Inc.
Sold By: Clinical sites; Distributors
Manufactured In: United States
Units Affected: 2 products (157 units (US); 220 units (US))
Distributed To: Minnesota, Maryland

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.