FDA recall Z-1475-2025

Stryker Corporation · Class II · device

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

Status
Ongoing
Initiation date
2025-02-25
Report date
2025-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

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