Agency classClass IIOur severity:High FDA (Devices)·Z-1475-2025·Announced 2025-04-09

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.

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: 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
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 (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.

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 →

Same manufacturer · Stryker Corporation

See all →

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Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
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Stryker Single Spike Tube Set Recalled for Leaking During Use
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Severe
Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
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Same hazard · sterility breach