Auckland, New Zealand
Adept Medical Ltd recalls
1 recall recorded since 2018, most recently on 24 November 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 November 2024
- Reason
- Lack of 510(k) clearance.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0966-2025, Z-0964-2025, Z-0969-2025, Z-0965-2025, Z-0967-2025, Z-0963-2025, Z-0968-2025, Z-0970-2025
- Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
- Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
- Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
- Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
- Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
- Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
- Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.