# FDA recall Z-2448-2021

> **Pentax of America Inc** · Class II · device recall initiated 2021-07-14.

## Product

Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel  Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L;  Colonoscope Family # 2-Pentax  Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK

## Reason for recall

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2448-2021
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-14
- **Report date:** 2021-09-22

- **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-2448-2021

## Citation

> AI Analytics. FDA recall Z-2448-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2448-2021. Source: US FDA. Licensed CC0.

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