Class II

Medical Device Recall: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044

Olympus Corporation of the Americas · December 11, 2023

Reason for Recall

The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

Distribution

Worldwide distribution - US Nationwide and the countries of Australia.

States Affected

NATIONWIDE

Quantity Affected

600 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1004-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.