# FDA recall Z-2713-2017

> **Pentax of America Inc** · Class II · device recall initiated 2017-01-17.

## 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.

## Distribution

Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.

## Key facts

- **Recall number:** Z-2713-2017
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-01-17
- **Report date:** 2017-07-19
- **Termination date:** 2018-03-08

- **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-2713-2017

## Citation

> AI Analytics. FDA recall Z-2713-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2713-2017. Source: US FDA. Licensed CC0.

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