FDA Device recall Z-0967-2025
Otological Ventilation Tube - T-Tube 12mm - 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 12mm - Silicone by Adept Medical, citing lack of 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0967-2025 |
| 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 12mm - Silicone; Product Code: NZ3312;
Reason
Lack of 510(k) clearance.
Identifiers
| code_info | Product Code: NZ3312; UDI-DI: 09421901970383; Lots: 2008-1461, 2011-2537, 2012-2689, 2012-2842, 2015-3945, 2015-4400, 2…Product Code: NZ3312; UDI-DI: 09421901970383; Lots: 2008-1461, 2011-2537, 2012-2689, 2012-2842, 2015-3945, 2015-4400, 2016-4554, 2016-4662, 2016-5199, 2016-5283, 2017-6007, 2019-6984, 2020-9242, 2020-9690, 2021-10187, 2021-9918, 2023-10966, |
|---|
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-0967-2025%22
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