Adept Medical Ltd: Medical Device Recall in 2025 - (Recall #: Z-0967-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

Product Classification:

Class II

Date Initiated: November 24, 2024

Date Posted: January 29, 2025

Recall Number: Z-0967-2025

Event ID: 95942

Reason for Recall:

Lack of 510(k) clearance.

Status: Ongoing

Product Quantity: 5,120 units (2190 US, 2930 OUS)

Code Information:

Product Code: NZ3312; UDI-DI: 09421901970383; Lots: 2008-1461, 2011-2537, 2012-2689, 2012-2842, 2015-3945, 2015-4400, 2016-4554, 2016-4662, 2016-5199, 2016-5283, 2017-6007, 2019-6984, 2020-9242, 2020-9690, 2021-10187, 2021-9918, 2023-10966,

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated