Obalon Therapeutics Inc: Medical Device Recall in 2020 - (Recall #: Z-1805-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 23, 2019

Date Posted: May 6, 2020

Recall Number: Z-1805-2020

Event ID: 85050

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.

Status: Completed

Product Quantity: 45 units

Code Information:

ObalonR Balloon System with Navigation and Touch. UDI: 00859810006104; Model No.: Model 4300 Touch Dispenser;Software version 02.00.00.0076. Serial Numbers: 0097, 0076, 0077, 0078, 0079, 0080, 0082, 0083, 0084, 0085, 0086, 0087 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0097, 0099, 0100, 0101, 0102, 0103, 0104, 0106, 0107, 0109, 0111, 0112, 0113, 0115, 0118, 0119, 0120, 0121, 0122, 0125, 0126, 0127, 0129, 0130, 0133.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated