Video Duodenoscope These instruments are intended to provide optical… — Class II medical device recall Z-2713-2017
Terminated recall by Pentax of America Inc, reported 2017-07-19, distributed nationwide. Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how
| Recall number | Z-2713-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2017-01-17 |
| Classified | 2017-07-10 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2018-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Model numbers | ED-3270K, ED-3490TK |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.