Class II — Lucid Diagnostics, Inc.
| Recalling firm | Lucid Diagnostics, Inc. |
|---|---|
| Registered facility | LUCID DIAGNOSTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. |
| Product | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A |
| Quantity | 220 units (US) |
| Distribution | US Nationwide distribution in the states of MN, MD. |
| Initiated | 2024-04-24 |
| Classified | 2024-05-24 |
| Recall number | Z-1900-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lucid Diagnostics, Inc. (Z-1900-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94510/
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