Recall Z-0707-2025— Olympus Corporation of the Americas

Name: FDA recall Z-0707-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-19

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-11-19. It names one FDA 510(k) clearance: K932166. Product: Duravent Silicone Ventilation Tube. Model Number: 240075.. Reason: Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-11-19
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K932166 — SILICONE TYMPANOSTOMY TUBESSmith & Nephew Richards, Inc.·cleared 1993-07-26

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

Duravent Silicone Ventilation Tube. Model Number: 240075.

Reason for recall

Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

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