Tobii Dynavox Llc: Medical Device Recall in 2023 - (Recall #: Z-1399-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

Product Classification:

Class II

Date Initiated: February 24, 2023

Date Posted: April 26, 2023

Recall Number: Z-1399-2023

Event ID: 91884

Reason for Recall:

Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Status: Ongoing

Product Quantity: 3924 units

Code Information:

UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated