FDA Device recall Z-2713-2017
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the…
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the… by Pentax, citing pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2713-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-17 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pentax |
| Distribution | US |
Product
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
Reason
Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Identifiers
| code_info | Model Numbers: Ed-3490TK and ED-3270K |
|---|
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-2713-2017%22
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