Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Numbe...
FDA Recall #Z-1475-2025 — Class II — February 25, 2025
Product Description
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
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.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
182,344 total units
Distribution
US Nationwide distribution.
Code Information
5400-020-100 UDI-DI: 07613327301656, Lot Numbers: 2022101016 2023021716 2023062115 2023082113 2024022114; 5400-020-100ITL UDI-DI: 07613327359497, Lot Numbers: 2023021715 2023100214 2023102315 2024012414 2024022615 2024041015 2024052114 2024082713 2023072513 2023100515 2023102615 2024012914 2024030515 2024041714 2024052415 2023082114 2023101015 2023111515 2024020117 2024030815 2024042214 2024060412 2023082915 2023101312 2024010813 2024021315 2024031314 2024050713 2024072912 2023092532 2023101815 2024011115 2024021615 2024040515 2024051414 2024081415
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated