FDA recall Z-0963-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-11-24

Report date

2025-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Auckland, New Zealand

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2025