# FDA recall Z-1805-2020

> **Obalon Therapeutics Inc** · Class II · device recall initiated 2019-05-23.

## Product

Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

## Reason for recall

During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

## Distribution

US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ.

## Key facts

- **Recall number:** Z-1805-2020
- **Recalling firm:** Obalon Therapeutics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-05-23
- **Report date:** 2020-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1805-2020

## Citation

> AI Analytics. FDA recall Z-1805-2020. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1805-2020. Source: US FDA. Licensed CC0.

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