Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Otological Ventilation Tube - T-Tube 6mm - Double - Silicone Recalled by Adept Medical Ltd Due to Lack of 510(k) clearance.

Date: November 24, 2024
Company: Adept Medical Ltd
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Adept Medical Ltd directly.

Affected Products

Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

Quantity: 2,010 units (630 US, 1380 OUS)

Why Was This Recalled?

Lack of 510(k) clearance.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Adept Medical Ltd

Adept Medical Ltd has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report