Otopore Cylinder Standard outer ear dressings recall: Sterility Concern
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Why was Otopore Cylinder Standard outer ear dressings 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013
- Product
- Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
- Recalling firm
- Stryker Corporation
- Quantity
- 182,344 total units
- Distribution
- US Nationwide distribution.
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)