Recall Z-0970-2025— Adept Medical Ltd

Name: FDA recall Z-0970-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-24

Class II · Ongoing

Class II FDA medical device recall by Adept Medical Ltd, initiated 2024-11-24. It names one FDA 510(k) clearance: K061058. Product: Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;. Reason: Lack of 510(k) clearance..

Recalling firm: Adept Medical Ltd
Classification: Class II
Status: Ongoing
Initiated: 2024-11-24
Firm location: Auckland, New Zealand

510(k) clearances named in this recall

1 on FDA's record

K061058 — NEOZOLINE VENTILATION TUBESAdept Medical, Ltd.·cleared 2006-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

Reason for recall

Lack of 510(k) clearance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.