CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
EsophaCap diameter, 10 pores/inch) recalled by Lucid Diagnostics
Lucid Diagnostics is recalling EsophaCap diameter, 10 pores/inch), distributed nationwide in the US. The recall was initiated on 24 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1900-2024
- FDA event ID
- 94510
- Recalling firm
- Lucid Diagnostics, Foxboro, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2024
- FDA classified
- 24 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 24 Apr 2024 | Recall initiated by company | |
| 24 May 2024 | Classified by FDA | +30 days |
| 5 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of MN, MD.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Code: Product sent out to clinical site: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 483 (Qty: 120), 502 (Qty: 100) Product at Distributor in Quarantine: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 539 (Qty: 99)
Where was it sold?
US Nationwide distribution in the states of MN, MD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94510| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | EsophaCap diameter, 20 pores/inch) recalled by Lucid Diagnostics | Lucid Diagnostics | Device Malfunction | Nationwide |
More recalls from Lucid Diagnostics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EsophaCap diameter, 20 pores/inch) recalled by Lucid Diagnostics | Lucid Diagnostics | Device Malfunction | Nationwide |
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| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |