FDA Device recall Z-0970-2025
Otological Ventilation Tube - Donaldson - Double - Blue 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 - Donaldson - Double - Blue Silicone by Adept Medical, citing lack of 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0970-2025 |
| 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 - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Reason
Lack of 510(k) clearance.
Identifiers
| code_info | Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790,…Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068. |
|---|
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-0970-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.