Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Recall date

November 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0963-2025

FDA classification

Class II

Brand / firm

Adept Medical Ltd

Sold / distributed

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.

Why it was recalled

Lack of 510(k) clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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