Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 26, 2023
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Tobii Dynavox Llc recalled Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambu… - a moderate-severity action.
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambu… was recalled by Tobii Dynavox Llc in April 26, 2023. Reason: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.. Check the official notice for the remedy. Verify recall #Z-1399-2023 with the FDA Devices before acting.
The recall
Tobii Dynavox Llc issued this moderate-severity FDA Devices recall-Problem maintaining the stable placement of the battery may come loose from the housing and become damaged..
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- April 26, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1399-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1399-2023) was formally reported on April 26, 2023, with the manufacturer initiating the action on February 24, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Tobii Dynavox Llc is listed as the recalling firm, operating out of Pittsburgh, PA. Federal records list the affected scope as 3924 units.
The documented reason for this recall is: Problem maintaining the stable placement of the battery may come loose from the housing and become damaged. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi…. 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
3924 units
Related Recalls
6
3 from same agency
Product description
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
Reason for recall
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1399-2023 |
| Date reported | April 26, 2023 |
| Date initiated | February 24, 2023 |
| Recalling firm | Tobii Dynavox Llc |
| Firm location | Pittsburgh, PA |
| Affected scope | 3924 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, S… |
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-1399-2023) 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? ▼
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567. Recalled by Tobii Dynavox Llc. Units affected: 3924 units.
Why was this product recalled? ▼
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1399-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, United Arab Emirates, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1399-2023) 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 April 26, 2023. 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.