Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen — Class II medical device recall Z-1805-2020
Completed recall by Obalon Therapeutics Inc, reported 2020-05-06, distributed nationwide. During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadv
| Recall number | Z-1805-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Obalon Therapeutics Inc, Carlsbad, CA, United States |
| Recall initiated | 2019-05-23 |
| Classified | 2020-04-28 |
| Reported by FDA | 2020-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
| UPC / GTIN / UDI-DI | 00859810006104 |
| Serial numbers | 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 and 19 more |
| Model numbers | 4300 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1805-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.