Otopore Cylinder Standard outer ear dressings — Class II medical device recall Z-1469-2025
Ongoing recall by Stryker Corporation, reported 2025-04-09, distributed nationwide. There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. T
| Recall number | Z-1469-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2025-02-25 |
| Classified | 2025-03-28 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 182,344 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 07613327301663, 07613327359510 |
| Lot numbers | 2023011112, 2023020334, 2023022132, 2023072413, 2023112213, 2024020515, 2024032013, 2024032615, 5400-010-000ITL |
| Model numbers | 5400-010-000, 5400-010-000ITL |
Product
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1469-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.