United StatesThe TD Navio Midi (Model/Catalog 1000798) and TD Navio Maxi (Model/Catalog 1000799) speech generating devices with serial numbers TDNM1-240628000004 through TDNM1-260617070001 and TDNL1-240904000016 through TDNL1-260617070001 (UDI-DI 073400747602056 and 073400747602070) are affected. They were recalled because battery mounting tabs may become damaged, allowing the battery to move and potentially cause an internal short, localized heating and gas venting.
What's being recalled
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Recalling firm: Tobii Dynavox Llc, Pittsburgh, PA, United States.
How to identify it
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). 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).
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)