RegWardenFDA facility compliance records
Company

Tobii Dynavox LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2023: 1 recalls; 2026: 1 recalls201720182019202020212022120232024202512026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-07-08
    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.
  • Class IIOngoing2023-02-24
    Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Tobii Dynavox LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9076359-tobii-dynavox-llc/

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