Otopore Square Outer Ear Wound Dressing Recall for Sterility Seal Defect
Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a wound dressing where the sterile barrier integrity is compromised. The product is a risk-of-harm device, and no illnesses or injuries have been reported, which per the rubric limits the score to 3 (High).
Plain-English summary
Stryker Corporation is recalling Otopore Square outer ear wound dressings in two product variants (Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL) affecting a total of 182,344 units distributed nationwide.
The recall is due to a potential defect in the blister seals on the packaging. These seals are designed to maintain the sterile barrier of the product. In some units, the seal may develop a bubble in the seal area, which indicates that the sterility barrier has been breached.
Affected consumers should stop using any of the recalled Otopore Square dressings and contact their healthcare provider or the manufacturer for guidance. Specific lot numbers are identified in the FDA recall notice and should be checked before use. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Wound Dressing
- Hazard
- sterility-breach
- packaging-seal-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 5400-020-100 UDI-DI: 07613327301656
- Lot Numbers: 2022101016 2023021716 2023062115 2023082113 2024022114
- 5400-020-100ITL UDI-DI: 07613327359497
Distribution
Distributed nationwide across the United States.
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