Adept Medical Ltd: Medical Device Recall in 2025 - (Recall #: Z-0969-2025)

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 - Blue Silicone; Product Code: NZ3321;

Product Classification:

Class II

Date Initiated: November 24, 2024

Date Posted: January 29, 2025

Recall Number: Z-0969-2025

Event ID: 95942

Reason for Recall:

Lack of 510(k) clearance.

Status: Ongoing

Product Quantity: 2,440 units (1940 US, 500 OUS)

Code Information:

Product Code: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.

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