Class II

Medical Device Recall: Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

Stryker Corporation · February 25, 2025

Reason for Recall

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

182,344 total units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1469-2025

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.