# FDA recall Z-1237-2025

> **Pentax of America Inc** · Class II · device recall initiated 2025-01-29.

## Product

PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract    Model: EG29-i20c

## Reason for recall

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). 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 membranes.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1237-2025
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-29
- **Report date:** 2025-03-05

- **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-1237-2025

## Citation

> AI Analytics. FDA recall Z-1237-2025. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1237-2025. Source: US FDA. Licensed CC0.

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