Esophagoscope (Flexible Or Rigid)

Name: Esophagoscope (Flexible Or Rigid) (FDA product code EOX) — devices, recalls & adverse events
Creator: U.S. Food & Drug Administration

FDA product code EOX · Class 2 · Ear, Nose, Throat

442

Registered devices

Adverse events

Recalls

510(k) clearances

Recent recalls

Date	Firm	Reason
2024-04-24	Lucid Diagnostics, Inc.	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 s
2024-04-24	Lucid Diagnostics, Inc.	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 s
2023-06-02	Covidien, LLC	Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to devic
2021-08-16	Olympus Corporation of the Americas	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati
2016-06-06	Covidien, LLC	Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withd
2016-06-06	Covidien, LLC	Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withd
2011-09-30	Pentax Medical Company	The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
2011-09-30	Pentax Medical Company	The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.