FDA Device recall Z-2277-2016
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract by Pentax Medical, citing pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2277-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-06 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pentax Medical |
| Distribution | US |
Product
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Reason
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Identifiers
| code_info | Model #'s FD-34V and ED-3490TK |
|---|
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-2277-2016%22
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