Otopore Outer Ear Dressings Recalled for Compromised Sterile Packaging Seals
Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.
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 a Class II recall of a medical device involving potential compromise of sterile packaging. No illnesses or injuries have been reported. As a risk-of-harm product with theoretical rather than realized harm, this meets the criteria for High severity.
Plain-English summary
Stryker Corporation is recalling 182,344 units of Otopore Cylinder Standard outer ear dressings with Catalog Numbers 5400-010-000 and 5400-010-000ITL distributed nationwide in the United States. The recall addresses a defect in the blister seals used on product packaging.
The defect involves potential bubbles forming on the blister seal area. Since these seals serve as the sterile barrier, the presence of a bubble indicates the seal has been compromised and sterility cannot be assured.
The affected lot numbers are as follows. For Catalog Number 5400-010-000: Lot Numbers 2023011112, 2023020334, 2023072413, and 2024032615. For Catalog Number 5400-010-000ITL: Lot Numbers 2023022132, 2023112213, 2024020515, and 2024032013.
Users who have these products should verify the lot number on their packages. If the lot number matches the affected lists above, the product should not be used. Affected patients and healthcare providers should consult together about appropriate follow-up regarding any dressings that may have already been applied from recalled lots.
The recalled product
- Product
- Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Ear Dressings
- Hazard
- seal-defect
- sterility-compromise
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 (7)
- 5400-010-000 UDI-DI: 07613327301663
- Lot Numbers:2023011112
- 2023020334
- 2023072413
- 2024032615
- 5400-010-000ITL UDI-DI: 07613327359510
- Lot Numbers: 2023022132 2023112213 2024020515 2024032013
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03