Carlsbad, CA, United States
Obalon Therapeutics Inc recalls
1 recall recorded since 2018, most recently on 23 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 23 May 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1805-2020
- 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 pr
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.