Class II

Medical Device Recall: Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Adept Medical Ltd · November 24, 2024

Reason for Recall

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.

States Affected

NATIONWIDE

Quantity Affected

13,070 units (9090 US, 3980 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0963-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.