Pentax Video Duodenoscope Model: ED-3490TK — Class II medical device recall Z-0643-2018
Terminated recall by Pentax of America Inc, reported 2018-02-28, distributed nationwide. The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the
| Recall number | Z-0643-2018 |
|---|---|
| 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 | 2018-02-13 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 559 |
| UPC / GTIN / UDI-DI | 04961333232420 |
| Model numbers | ED-3490TK |
Product
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) 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
The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0643-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.