# FDA recall Z-1775-2020

> **Medivators, Inc.** · Class II · device recall initiated 2019-10-09.

## Product

Medivators Endo Smartcap Endoscope Tubing.  REF100145CO2EXT, packaged  as Contents  1, 10, 50, and found in BMP-C145CO2EXT.  Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input.  Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

## Reason for recall

Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, England.

## Key facts

- **Recall number:** Z-1775-2020
- **Recalling firm:** Medivators, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-09
- **Report date:** 2020-04-29
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2020

## Citation

> AI Analytics. FDA recall Z-1775-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1775-2020. Source: US FDA. Licensed CC0.

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