Recall Z-1475-2025— Stryker Corporation
Class II · Ongoing
Class II FDA medical device recall by Stryker Corporation, initiated 2025-02-25. It names one FDA 510(k) clearance: K070715. Product: Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL. Reason: 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..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-25
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.