FDA Device recall Z-2079-2016
Esophagoscope Gastrointestinal Tract
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Esophagoscope Gastrointestinal Tract by Pentax Medical, citing pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2079-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-06 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pentax Medical |
| Distribution | US |
Product
Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Reason
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Identifiers
| code_info | Model #'s EE-1540 and EE-1580k |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2079-2016%22
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