Stryker recalls Otopore Cylinder outer ear wound dressings with specific catalog numbers and lot ranges due to potential sterility seal breaches that could compromise infection control.
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 certain Otopore Cylinder outer ear wound dressings because the packaging's sterility seal might be broken, which could mean the product isn't sterile and might cause infection. This is a safety issue for people using the product for ear wounds.
The packaging has a sterility seal that should stay intact to keep the product sterile. If this seal is broken, it could mean the dressing isn't sterile anymore and might lead to infection if used on an open wound.
People who own or use the recalled Otopore Cylinder outer ear wound dressings with the specific catalog numbers and lot ranges listed in the recall. Those most at risk are individuals using the product for ear wounds who might have the seal compromised.
Check for the product name 'Otopore Cylinder outer ear wound dressing' with catalog numbers 5400-020-000 or 5400-020-000TL. Look for specific lot numbers listed in the recall, which include many date ranges from 2022 to 2024.
Identify if your Otopore Cylinder outer ear wound dressing has the catalog numbers 5400-020-000 or 5400-020-000TL and the listed lot numbers.
The recall is because the sterility seal on the packaging might be broken, which could mean the product isn't sterile and might cause infection if used on an open wound.
Check if your product has the specific catalog numbers and lot numbers listed in the recall. If it does, you should stop using it and contact Stryker for further instructions.
The recall states there is a potential for the sterility seal to be breached, which could lead to infection. However, the risk is low and does not involve immediate serious injury like death or severe harm.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1472-2025 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1472-2025 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.
