Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Reported: April 9, 2025 Initiated: February 25, 2025 #Z-1472-2025
Product Description
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Reason for Recall
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.
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 182,344 total units
- Distribution
- US Nationwide distribution.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL. Recalled by Stryker Corporation. Units affected: 182,344 total units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1472-2025.
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