Stryker Corporation 2025-04-09 Health serious FDA
Health · FDA · Recall #FDA-Z-1475-2025
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte… Recall
Issued April 9, 2025 · Stryker Corporation
In April 2025, Stryker Corporation recalled the Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Stryker Corporation
- Category
- Health
- Recall date
- April 9, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1475-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Corporation has 15 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.