FDA Medical devices recall ·
Otological Ventilation Tube - Donaldson - Double - Blue Silicone recall
- Recall number
- Z-0970-2025
- Date
- (initiated November 24, 2024)
- Company / brand
- Adept Medical Ltd
2-6 Mc Donald Street, Auckland, New Zealand - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,080 units (1510 US, 2570 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Why was it recalled?
Lack of 510(k) clearance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0970-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.