{"recall":{"id":"fda-device-99410","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Tobii Dynavox Llc recalls 2 products","firm":"Tobii Dynavox Llc","date":"2026-07-08","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798","code":"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).","quantity":"","number":"Z-2959-2026","classification":"Class II"},{"name":"TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799","code":"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).","quantity":"","number":"Z-2960-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99410","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d57447e50813733b","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99410","record":[{"status":"Ongoing","city":"Pittsburgh","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99410","recalling_firm":"Tobii Dynavox Llc","address_1":"2100 Wharton St Ste Ste 400","address_2":"","postal_code":"15203-1691","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2959-2026","product_description":"TD Navio Midi Speech Generating Device  Model/Catalog Number: 1000798","product_quantity":"","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.","recall_initiation_date":"20260708","center_classification_date":"20260814","report_date":"20260826","code_info":"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).","more_code_info":""},{"status":"Ongoing","city":"Pittsburgh","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99410","recalling_firm":"Tobii Dynavox Llc","address_1":"2100 Wharton St Ste Ste 400","address_2":"","postal_code":"15203-1691","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2960-2026","product_description":"TD Navio Maxi Speech Generating Device  Model/Catalog Number: 1000799","product_quantity":"","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.","recall_initiation_date":"20260708","center_classification_date":"20260814","report_date":"20260826","code_info":"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).","more_code_info":""}]}}