Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Class I - DangerousWhat Should You Do?
- Check if you have this product: 5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Product Codes/Lot Numbers:
5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1469-2025
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