Adept Medical Ltd: Medical Device Recall in 2025 - (Recall #: Z-0963-2025)

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 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Product Classification:

Class II

Date Initiated: November 24, 2024

Date Posted: January 29, 2025

Recall Number: Z-0963-2025

Event ID: 95942

Reason for Recall:

Lack of 510(k) clearance.

Status: Ongoing

Product Quantity: 13,070 units (9090 US, 3980 OUS)

Code Information:

Product Code: NZ3306; UDI-DI: 09421901970345 (NZ3306); Lots: 2008-1457, 2008-1525, 2009-1845, 2010-2037, 2011-2486, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2020-9292, 2020-9476, 2022-10874, 2023-11128, 2023-11542,

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