Adept Medical Ltd: Medical Device Recall in 2025 - (Recall #: Z-0970-2025)

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 - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

Product Classification:

Class II

Date Initiated: November 24, 2024

Date Posted: January 29, 2025

Recall Number: Z-0970-2025

Event ID: 95942

Reason for Recall:

Lack of 510(k) clearance.

Status: Ongoing

Product Quantity: 4,080 units (1510 US, 2570 OUS)

Code Information:

Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068.

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