medical Class II Updated 2025-04-09

Stryker Corporation recalls Otopore Cylinder Standard outer ear dressings, Catalog Numbe

Recalled Product

Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013
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