Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported May 6, 2020
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.
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…
Obalon Therapeutics Inc recalled Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00… - a moderate-severity action.
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00… was recalled by Obalon Therapeutics Inc in May 6, 2020. Reason: During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inad…. Check the official notice for the remedy. Verify recall #Z-1805-2020 with the FDA Devices before acting.
The recall
Obalon Therapeutics Inc issued this moderate-severity FDA Devices recall-During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inad….
- Moderate
- severity level
- 45 units
- affected scope
- Class II
- classification
- May 6, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1805-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1805-2020) was formally reported on May 6, 2020, with the manufacturer initiating the action on May 23, 2019. It is classified under Moderate severity (Class II), with a current status of Completed. Obalon Therapeutics Inc is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 45 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
45 units
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-1805-2020 |
| Date reported | May 6, 2020 |
| Date initiated | May 23, 2019 |
| Recalling firm | Obalon Therapeutics Inc |
| Firm location | Carlsbad, CA |
| Affected scope | 45 units |
| Distribution | US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1805-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Obalon Therapeutics Inc. Units affected: 45 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1805-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1805-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 6, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.