Otological Ventilation Tube — Class II medical device recall Z-0970-2025
Ongoing recall by Adept Medical Ltd, reported 2025-01-29, distributed nationwide. Lack of 510(k) clearance.
| Recall number | Z-0970-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Adept Medical Ltd, Auckland, New Zealand |
| Recall initiated | 2024-11-24 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CL, DE, ES, GB, GR, HK, IE, IT, MY, NZ, PE, SV, TR |
| UPC / GTIN / UDI-DI | 09421901970413 |
| Lot numbers | 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 |
Product
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Reason for recall
Lack of 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0970-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.