Otopore Cylinder Wound Dressing Recalled for Potential Sterility Seal Defect
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II sterility barrier defect on a wound dressing. The potential breach of sterile seals creates risk of contamination in open wounds, but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury score High.
Plain-English summary
Stryker Corporation is recalling Otopore Cylinder outer ear wound dressing (Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL). The recall affects 182,344 total units distributed nationwide in the United States.
The product's blister seals function as the sterile barrier. The defect appears as bubbles in the seal area of the packaging. When a bubble is present, it indicates the sterility seal has been breached. A breached seal means the product cannot maintain its intended sterile condition before use.
This is a Class II medical device recall issued by the FDA.
The recalled product
- Product
- Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Wound Dressing
- Affected units
- 182,344
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 (2)
- 5400-020-000 UDI-DI: 07613327301670
- 5400-020-000ITL UDI-DI: 07613327359466
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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