Recall archive / FDA device enforcement
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL — FDA record Z-1475-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Stryker Corporation
- Quantity
- 182,344 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1475-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 5400-020-100 UDI-DI: 07613327301656, Lot Numbers: 2022101016 2023021716 2023062115 2023082113 2024022114; 5400-020-100ITL UDI-DI: 07613327359497, Lot Numbers: 2023021715 2023100214 2023102315 2024012414 2024022615 2024041015 2024052114 2024082713 2023072513 2023100515 2023102615 2024012914 2024030515 2024041714 2024052415 2023082114 2023101015 2023111515 2024020117 2024030815 2024042214 2024060412 2023082915 2023101312 2024010813 2024021315 2024031314 2024050713 2024072912 2023092532 2023101815 2024011115 2024021615 2024040515 2024051414 2024081415 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 9, 2025
- Recall initiation date
- Feb 25, 2025
- Center classification date
- Mar 28, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.