FDA Device recall Z-0963-2025
Otological Ventilation Tube - T-Tube 6mm - 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 6mm - Silicone by Adept Medical, citing lack of 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0963-2025 |
| 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 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Reason
Lack of 510(k) clearance.
Identifiers
| code_info | Product Code: NZ3306; UDI-DI: 09421901970345 (NZ3306); Lots: 2008-1457, 2008-1525, 2009-1845, 2010-2037, 2011-2486, 201…Product Code: NZ3306; UDI-DI: 09421901970345 (NZ3306); Lots: 2008-1457, 2008-1525, 2009-1845, 2010-2037, 2011-2486, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2020-9292, 2020-9476, 2022-10874, 2023-11128, 2023-11542, |
|---|
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-0963-2025%22
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