Facility

DYNAVOX Group AB

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

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005301283
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	Lojtnantsgatan 25 Stockholm, SE 11550
Registration status	Active · expires 2026
Parent company	Tobii Dynavox LLC (owner-operator 9076359)
Brand names	TD I-110; I-16; I-15+; I-12+; I-110; TD Pilot; I-13; TD I-16; TD I-13

Activity by year

Recalls (2)

Devices registered here (1)

System, Communication, Powered
Product code ILQ (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.3710

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.

All facilities operated by Tobii Dynavox LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DYNAVOX Group AB (FEI 3005301283) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005301283-dynavox-group-ab/

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