FDA Device recall Z-1805-2020
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen
- FDA Device
- Class II
- completed
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen by Obalon Therapeutics, citing 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 touchscre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1805-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-05-23 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Obalon Therapeutics |
| Distribution | US |
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
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.
Identifiers
| code_info | ObalonR Balloon System with Navigation and Touch. UDI: 00859810006104; Model No.: Model 4300 Touch Dispenser;Software…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1805-2020%22
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