FDA Device recall Z-0966-2025
Otological Ventilation Tube - T-Tube 9mm - Silicone
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of Otological Ventilation Tube - T-Tube 9mm - Silicone by Adept Medical, citing lack of 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0966-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-24 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Adept Medical |
| Distribution | US |
Product
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Reason
Lack of 510(k) clearance.
Identifiers
| code_info | Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2…Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2014-3783, 2014-3832, 2015-3943, 2016-4601, 2016-5197, 2017-5651, 2017-6150, 2018-6487, 2018-6818, 2019-7211, 2021-10033, 2022-10783, 2023-11053, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0966-2025%22
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