Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Class I - DangerousWhat Should You Do?
- Check if you have this product: 5400-020-100 UDI-DI: 07613327301656, Lot Numbers: 2022101016 2023021716 2023062115 2023082113 2024022114; 5400-020-100ITL UDI-DI: 07613327359497, Lot Numbers: 2023021715 2023100214 2023102315 2024012414 2024022615 2024041015 2024052114 2024082713 2023072513 2023100515 2023102615 2024012914 2024030515 2024041714 2024052415 2023082114 2023101015 2023111515 2024020117 2024030815 2024042214 2024060412 2023082915 2023101312 2024010813 2024021315 2024031314 2024050713 2024072912 2023092532 2023101815 2024011115 2024021615 2024040515 2024051414 2024081415
- 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 Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Product Codes/Lot Numbers:
5400-020-100 UDI-DI: 07613327301656, Lot Numbers: 2022101016 2023021716 2023062115 2023082113 2024022114; 5400-020-100ITL UDI-DI: 07613327359497, Lot Numbers: 2023021715 2023100214 2023102315 2024012414 2024022615 2024041015 2024052114 2024082713 2023072513 2023100515 2023102615 2024012914 2024030515 2024041714 2024052415 2023082114 2023101015 2023111515 2024020117 2024030815 2024042214 2024060412 2023082915 2023101312 2024010813 2024021315 2024031314 2024050713 2024072912 2023092532 2023101815 2024011115 2024021615 2024040515 2024051414 2024081415
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1475-2025
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