Tobii Dynavox recall: TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 and 1 more product
Tobii Dynavox Llc is recalling TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 and 1 more product. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 8, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Share
| Product | TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 and 1 more product |
| Brand | Tobii Dynavox |
| Company | Tobii Dynavox Llc |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 8, 2026 |
| Published by FDA | August 26, 2026 |
| Recall ID | 99410 |
Recalled products (2)
- TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
- FDA recall number
- Z-2959-2026
- Codes, lots and dates
- UDI-DI 073400747602056 Serial Numbers TDNM1-240628000004 through TDNM1-260617070001. Corrected/future production is differentiated by new serialization from TDNM1-260617070001 onward (production batch 20260615, improved design).
- Classification
- Class II
- TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
- FDA recall number
- Z-2960-2026
- Codes, lots and dates
- UDI-DI 073400747602070 Serial Numbers TDNL1-240904000016 through TDNL1-260617070001. Corrected/future production is differentiated by new serialization from TDNL1-260617070001 onward (production batch 20260615, improved design).
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99410
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Pittsburgh, PA, United States
Why it was recalled
The reason the FDA lists: “Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99410, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Tobii Dynavox TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 recalled?
Yes. Tobii Dynavox Llc recalled it on July 8, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.