Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen Recalled by Obalon Therapeutics Inc Due to During initial set-up and/or replacement of the dispenser...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Obalon Therapeutics Inc directly.
Affected Products
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.
Quantity: 45 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Obalon Therapeutics Inc
Obalon Therapeutics Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report