FDA Device recall Z-2066-2016
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity 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-2066-2016 |
| 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
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut 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 ECN-1530 and FCN-15X |
|---|
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-2066-2016%22
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