Obalon Therapeutics recalls specific model 4300 Touch Dispenser units with software version 02.00.00.0076 due to touchscreen calibration issues that may prevent balloon inflation during use.
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.
Obalon Therapeutics is recalling balloon systems with Model 4300 Touch Dispenser units and software version 02.00.00.0076. The touchscreen may become unresponsive during setup or balloon administration, preventing inflation. This could lead to failed treatments if the device isn't properly calibrated.
The touchscreen can lose calibration during battery replacement or when pressed while the device is powered on. This causes the screen to become unresponsive, preventing the balloon inflation process from starting. As a result, the treatment may not work as intended.
Patients using the Obalon Balloon System with Model 4300 Touch Dispenser and software version 02.00.00.0076 are affected. Those who have recently replaced dispenser batteries or pressed the touchscreen while powered on are at higher risk of failed treatments.
Check for the Model 4300 Touch Dispenser with software version 02.00.00.0076. Serial numbers include 0097, 0076 through 0133. The product was sold with the Obalon Balloon System for weight management.
Test if the touchscreen responds to touch during setup or balloon administration. If it becomes unresponsive, stop using the device immediately.
Reach out to Obalon Therapeutics for guidance on recalibrating the touchscreen or alternative solutions.
The touchscreen can lose calibration during battery replacement or when pressed while powered on, preventing balloon inflation.
Look for the Model 4300 Touch Dispenser with software version 02.00.00.0076. Serial numbers include 0097, 0076 through 0133.
No, but if the touchscreen becomes unresponsive during use, stop using it immediately to prevent failed treatments.
We’ve drafted a message you can send Obalon to request your refund or repair — edit it as you like.
Subject: Recall Z-1805-2020 — Obalon Obalon Hello, I own a Obalon that is covered by recall Z-1805-2020 from Obalon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
