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U.S. Department of Health and Human Services

Class 2 Device Recall TD Navio Maxi

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 Class 2 Device Recall TD Navio Maxisee related information
Date Initiated by FirmJuly 08, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2960-2026
Recall Event ID 99410
Product Classification System, communication, powered - Product Code ILQ
ProductTD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Code Information 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).
FEI Number 3004959902
Recalling Firm/
Manufacturer		 Tobii Dynavox Llc
2100 Wharton St Ste Ste 400
Pittsburgh PA 15203-1691
For Additional Information ContactBob Lizewski
+1-800-3441778 Ext. 1
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn July 8, 2026, the firm notified customers by emailing letters titled "URGENT: MEDICAL DEVICE RECALL NOTICE." Customers were informed that Tobii Dynavox would provide a repair authorization number (RA#), prepaid shipping label, inspection, repair, and return shipping for the affected device. The repair will include modifications intended to improve battery stability within the device. Customers were provided with ways to contact the company to obtain a repair authorization number. Customers were informed that it is safe to continue using the device as intended while waiting for the repair, as long as there are no signs of overheating, swelling, unusual odor, smoke, deformation, or battery abnormality. If any of these conditions are observed, discontinue use immediately and contact Tobbi Dynavox.
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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