# FDA recall Z-2329-2025

> **Pentax of America Inc** · Class II · device recall initiated 2025-07-16.

## Product

Pentax Medical Video Processor;  Model Number: EPK-i8020c;

## Reason for recall

During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

## Distribution

US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.

## Key facts

- **Recall number:** Z-2329-2025
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-16
- **Report date:** 2025-08-27

- **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-2329-2025

## Citation

> AI Analytics. FDA recall Z-2329-2025. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2329-2025. Source: US FDA. Licensed CC0.

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