Brand Name: EsophaCap Product Name: EsophaCap — Class II medical device recall Z-1900-2024
Ongoing recall by Lucid Diagnostics, Inc., reported 2024-06-05, distributed nationwide. The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from t
| Recall number | Z-1900-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lucid Diagnostics, Inc., Foxboro, MA, United States |
| Recall initiated | 2024-04-24 |
| Classified | 2024-05-24 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 220 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00860007510977 |
| Lot numbers | 483, 539 |
| Model numbers | EC25T10VI |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1900-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.