# FDA recall Z-1475-2025

> **Stryker Corporation** · Class II · device recall initiated 2025-02-25.

## Product

Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1475-2025
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-25
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2025

## Citation

> AI Analytics. FDA recall Z-1475-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1475-2025. Source: US FDA. Licensed CC0.

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