# FDA recall Z-1682-2021

> **Pentax of America Inc** · Class II · device recall initiated 2021-04-21.

## Product

Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.

## Reason for recall

IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient.  Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result  in aspiration

## Distribution

US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.

## Key facts

- **Recall number:** Z-1682-2021
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-21
- **Report date:** 2021-06-02
- **Termination date:** 2024-02-05

- **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-1682-2021

## Citation

> AI Analytics. FDA recall Z-1682-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1682-2021. Source: US FDA. Licensed CC0.

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