# FDA recall Z-0643-2018

> **Pentax of America Inc** · Class II · device recall initiated 2018-02-13.

## 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.

## Distribution

USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and  WY, and  the District of Columbia.

## Key facts

- **Recall number:** Z-0643-2018
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-13
- **Report date:** 2018-02-28
- **Termination date:** 2020-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montvale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0643-2018

## Citation

> AI Analytics. FDA recall Z-0643-2018. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0643-2018. Source: US FDA. Licensed CC0.

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