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Recall Observatory FDA recall evidence

Device product

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

Z-1469-2025

February 25, 2025

Class II

Product summary

Firm
Stryker Corporation
Event
Event 96393
Status
Ongoing
Classification
Class II
Quantity
182,344 total units
Official record key
device-enforcement:Z-1469-2025

Official wording

Reason: 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.

Code information: 5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.