# FDA recall Z-1900-2024

> **Lucid Diagnostics, Inc.** · Class II · device recall initiated 2024-04-24.

## 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

## Reason for recall

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.

## Distribution

US Nationwide distribution in the states of MN, MD.

## Key facts

- **Recall number:** Z-1900-2024
- **Recalling firm:** Lucid Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-24
- **Report date:** 2024-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foxboro, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1900-2024

## Citation

> AI Analytics. FDA recall Z-1900-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1900-2024. Source: US FDA. Licensed CC0.

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