Stryker recalls Otopore Cylinder Standard outer ear dressings with catalog numbers 5400-010-000 and 5400-010-000ITL due to potential sterility seal breach. Affected items have specific lot numbers and may not be sterile.
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.
Stryker is recalling Otopore Cylinder Standard outer ear dressings with specific catalog numbers and lot dates because the sterility seal might be broken, risking infection. This means the dressings could no longer be sterile if the seal is compromised.
The product has a blister seal that acts as a sterile barrier. If this seal is broken, it can indicate that the dressing is no longer sterile, potentially leading to infection. The seal's integrity is critical for maintaining sterility during medical use.
People who purchased or use Otopore Cylinder Standard outer ear dressings with the listed catalog numbers and lot dates are affected. Those with open wounds or sensitive skin may be at higher risk of infection.
Check for catalog numbers 5400-010-000 or 5400-010-000ITL. Lot numbers include 2023011112, 2023020334, 2023072413, 2024032615 for the first catalog number and 2023022132, 2023112213, 2024020515, 2024032013 for the second.
Verify the catalog number and lot numbers listed in the recall notice to confirm if your item is affected.
The recall is due to a potential breach in the sterility seal, which could mean the dressing is no longer sterile and may lead to infection.
The official recall notice does not specify a remedy, so you should check with Stryker Corporation directly for further instructions.
Check the catalog number (5400-010-000 or 5400-010-000ITL) and lot numbers listed in the recall notice.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1469-2025 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1469-2025 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
