Adept Medical Ltd: Medical Device Recall in 2025 - (Recall #: Z-0966-2025)

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 9mm - Silicone; Product Code: NZ3309;

Product Classification:

Class II

Date Initiated: November 24, 2024

Date Posted: January 29, 2025

Recall Number: Z-0966-2025

Event ID: 95942

Reason for Recall:

Lack of 510(k) clearance.

Status: Ongoing

Product Quantity: 6,280 units (2500 US, 3780 OUS)

Code Information:

Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2014-3783, 2014-3832, 2015-3943, 2016-4601, 2016-5197, 2017-5651, 2017-6150, 2018-6487, 2018-6818, 2019-7211, 2021-10033, 2022-10783, 2023-11053,

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