Stryker recalls Otopore Square ear wound dressings with potential sterility seal breaches. If the seal shows a bubble, the dressing may not be sterile. Consumers should check packaging for blister seal bubbles before use.
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 Square outer ear wound dressings that may have a broken sterility seal. This could mean the dressing isn't sterile and might cause infection if used. The recall affects specific product lots and catalog numbers.
The product's blister seal is supposed to keep the dressing sterile. If the seal shows a bubble, it means the sterility barrier has been broken. This could allow bacteria to enter the wound, increasing infection risk.
People who own or use the recalled Otopore Square ear wound dressings with the listed catalog numbers and lot dates are affected. Those with open ear wounds are at higher risk if the dressing isn't sterile.
Check the packaging for a blister seal with a bubble. The product has specific catalog numbers (5400-020-100 or 5400-020-100ITL) and lot dates listed in the recall notice.
Look for a bubble on the blister seal area of the packaging. If present, the sterility barrier may be broken.
Yes, the recall only applies if the blister seal shows a bubble. Normal seals indicate the dressing is sterile.
Affected lots include 2022101016, 2023021716, and other specific dates listed in the recall notice.
Discard the product immediately as it may not be sterile and could cause infection.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1475-2025 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1475-2025 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.
