Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Otopore Cylinder Standard outer ear dressings Recalled by Stryker Corporation Due to There is a potential for blister seals on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Corporation directly.
Affected Products
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Quantity: 182,344 total units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Corporation
Stryker Corporation has 108 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report