# FDA recall Z-0502-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2020-10-16.

## Product

Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.

## Reason for recall

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

## Distribution

Worldwide distribution - US Nationwide distribution.    Model Name        ------------   Quantity distributed in U.S.    GF-UC140P-AL5  ------------- 1,297 devices  GF-UCT150-AL5  -------------  564 devices  GF-UCT180 --------------------  3,145 devices  GF-UM20 -----------------------     31 devices  GF-UM130 ---------------------     27 devices  GF-UMQ130 -------------------   373 devices  GF-UM160 ---------------------   299 devices  GF-UC160P-OL5 -------------    46 devices  GF-UCT160-OL5 -------------    49 devices  GF-UE160-AL5  -------------- 2,691 devices

## Key facts

- **Recall number:** Z-0502-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-16
- **Report date:** 2020-12-09
- **Termination date:** 2022-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2021

## Citation

> AI Analytics. FDA recall Z-0502-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0502-2021. Source: US FDA. Licensed CC0.

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