# FDA recall Z-1267-2020

> **Pentax of America Inc** · Class II · device recall initiated 2020-01-03.

## Product

Pentax Video Colonoscope  Model:  EC34-i10L

## Reason for recall

Distributed in the USA without an approved 510K

## Distribution

NC, MA

## Key facts

- **Recall number:** Z-1267-2020
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-03
- **Report date:** 2020-02-26
- **Termination date:** 2021-01-26

- **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-1267-2020

## Citation

> AI Analytics. FDA recall Z-1267-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1267-2020. Source: US FDA. Licensed CC0.

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